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DEHP Product Notification

To Whom It May Concern:

Reorder codes EEAORVIL21A and EEAORVIL25A contain PVC but do not have DEHP. Below is the comprehensive list of products containing PVC with DEHP.

120059Chemosite™ venous access 8” line ext, 22 gauge
120068 Chemosite™ venous access 8” line ext, 22 gauge
120069 Chemosite™ venous access 8” line ext, 20 gauge
120072 Chemosite™ venous access 8” line ext, 22 gauge
120073Chemosite™ venous access 8” line ext, 20 gauge
120074 Chemosite™ venous access 8” line ext, 19 gauge
120075 Chemosite™ venous access 8” line ext, 19 gauge
120076 Chemosite™ venous access 8” line ext, 19 gauge
120077 Chemosite™ venous access 8” line ext, 20 gauge
178081Surgiwand™ II 5 mm Suction/Irrigator - Suction/irrigation device without tubing.
178082 Surgiwand™ II 5 mm Suction/Irrigator - Suction/irrigation device with tubing EPS-34 cm
178083 Surgiwand™ II 5 mm Suction/Irrigator - Suction/irrigation device with tubing GFS-34 cm
178091Surgiwand™ II 5 mm w/Caut/L-Hook
178092 Surgiwand™ II 5 mm w/Caut/L-Hook/Tube/EPS
178093 Surgiwand™ II 5 mm w/Caut/L-Hook/Tube/GFS
178094 Surgiwand™ II 5 mm w/Caut/Spatula/Tub/GFS
178095 Surgiwand™ II 5 mm w/CAUT/Spatula/Tube/EPS
898500 Snowden Pencer™ Breast Balloon DISS 900ml
898501 Snowden Pencer™ Breast Balloon DISCT 1000ML
OMSXB1 Spacemaker™ Extra View Balloon - Round
OMSXB2 Spacemaker™ Extra View Balloon - Oval
SMKDN Spacemaker™ Dissection Balloon - Kidney
SMOVL Spacemaker™ Dissection Balloon - Oval
SMRND Spacemaker™ Dissection Balloon - Round
SMSBT Spacemaker™ Structural Balloon Trocar
SMBTTOVLSpacemaker™ Plus BTT/Oval Balloon Dissector
SMBTTRNDSpacemaker™ Plus BTT/Round Balloon Dissector
SMSBTOVLSpacemaker™ Plus SBT/Oval Balloon Dissector
SMSBTRNDSpacemaker™ Plus SBT/Round Balloon Dissector
SMBTTRNDXSpacemaker™ Pro BTT and Round
SMBTTOVLXSpacemaker™ Pro BTT and Oval
SMSBTRNDXSpacemaker™ Pro SBT and Round
SMSBTOVLXSpacemaker™ Pro SBT and Oval
171312 Miniport™ 2 mm Sleeve w/Insufflation
171313Miniport™ 2 mm Introducer w/Insufflation
171315Miniport™ 2 mm Introducer - Short
171317Miniport™ 2 mm Sleeve - Short
8886827906Vital Vue™ System, Yankauer-Bulb Tip
8886828006Vital Vue™ System, Extended Yankauer-Bulb Tip
8886828106Vital Vue™ System, Extended Yankauer-Slender Tip
8886828206Vital Vue™ System, Yankauer Type Shape
8886828306Vital Vue™ System, Extra Long Orthopedic Tip

Should you have any further questions, please contact our Biological Services group Sr. Quality Supervisor, or Nicole.Grant@Medtronic.com.

Latex Product Notification

To Whom It May Concern:

With the exception of the devices listed below, all other Medtronic Minimally Invasive Therapies surgical devices are not made with natural rubber latex. The packaging used for the Medtronic Minimally Invasive Therapies surgical devices is not made with natural rubber latex.

The following devices have been identified to contain latex:

  1. The Blunt Tip Trocar products, (Reorder Codes: OMST10BT, OMST10BTS, OMST12BT)
  2. SEPS products using the balloon anchoring system, (Reorder Codes: VBT240T, VBT300, SMBTTRND, and SMBTTOVL)

    The latex in the listed reorder codes 1 and 2 is the base material of the trocar balloon, which is encapsulated in a silicone rubber material. In normal use there is no patient contact. In the unlikely event of a balloon rupture, the latex may come into contact with the patient.

  3. The AcuClip™ device (OMSA8) includes latex tubing enclosed in the handle, which does not come in contact with the patient at any time.

All other Medtronic Minimally Invasive Therapies surgical devices do not contain any latex. None of the packaging used for the Medtronic Minimally Invasive Therapies surgical devices contain latex.

Should you have any further questions, please contact our LaboratoryServices group Sr. Supervisor Quality at 203-492-5548, or Nicole.Grant@Medtronic.com.

Magnetic Resonance Imaging (MRI) and Nuclear Magnetic Resonance (NMR) procedures

To Whom It May Concern:

MRI INFORMATION

The [implantable component] in the [product family] are MR conditional.

Static Magnetic Field

Non-clinical testing demonstrated that a representative [implantable component] is MR conditional. A patient with these [implantable components] can be scanned safely immediately after placement of the [implantable component] under the following conditions:

  • Static magnetic field of 3-Tesla or less
  • Maximum spatial gradient magnetic field of 3000-Gauss/cm or less

MRI Related Heating

In non-clinical testing, the [implantable component] produced the following temperature rise during MRI performed for 15 minutes in the 3-Tesla, (SIEMENS Magnetom Verio Syngo 3T scanner; active-shielded, horizontal field, Methodist Research Hospital, Houston TX MR system:

Highest temperature change: + [insert temperature] o C

Therefore, the MRI related heating experiments for the [implantable component] at 3 Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged SAR of 2-W/kg indicated that the greatest amount of heating that occurred in associated with these specific conditions was equal to or less than + [insert temperature] o C after 15 minutes of continuous scanning.

Artifact Information

In non-clinical testing, the image artifact caused by the [implantable component] extends approximately [insert distance] mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the [implantable component]. Therefore, optimization of MR imaging parameters to compensate for the presence of this [implantable component] may be necessary.

Product FamilyImplantable ComponentHighest Temperature ChangeWhole Body Average Temperature ChangeImage Artifact Distance
LDS, PLDSTitanium Staple3.2°C2.3°C2 mm
EEA, CEEATitanium Staple3.2°C2.3°C2 mm
TA, PMFTATitanium Staple3.2°C2.3°C2 mm
ENDO GIA, DST GIATitanium Staple3.2°C2.3°C2 mm
ILA Titanium Staple3.2°C2.3°C2 mm
RoticulatorTitanium Staple3.2°C2.3°C2 mm
PI StaplerTitanium Staple3.2°C2.3°C2 mm
Endo HerniaTitanium Staple3.2°C2.3°C2 mm
Reliamax Titanium Staple3.2°C2.3°C2 mm
GIA PremiumStainless Steel Staple3.3°C2.3°C2 mm
PI DLUStainless Steel Staple3.3°C2.3°C2 mm
Multifire PremiumStainless Steel Staple3.3°C2.3°C2 mm
SignetStainless Steel Staple3.3°C2.3°C2 mm
Appose Stainless Steel Staple3.3°C2.3°C2 mm
SM 35 Stainless Steel Staple3.3°C2.3°C2 mm
DFS Stainless Steel Staple3.3°C2.3°C2 mm
PurstringStainless Steel Staple3.3°C2.3°C2 mm
Endo ClipTitanium Clip2.2°C2.3°C6 mm
Premium SurgiclipTitanium Clip2.2°C2.3°C6 mm
AcuClip Titanium Clip2.2°C2.3°C6 mm
MultApplier Titanium Clip2.2°C2.3°C6 mm
HerculonTitanium Anchor2.8°C2.3°C18 mm

MRI INFORMATION

The [implantable component] in the [product family] are MR conditional.

Static Magnetic Field

Non-clinical testing demonstrated that a representative [implantable component] is MR conditional. A patient with these [implantable components] can be scanned safely immediately after placement of the [implantable component] under the following conditions:

  • Static magnetic field of 3-Tesla or less
  • Maximum spatial gradient magnetic field of 720-Gauss/cm or less

MRI Related Heating

In non-clinical testing, the titanium clip produced the following temperature rise during MRI performed for 15 minutes in the 3-Tesla (3 Tesla/128 MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system:

Highest temperature change: + [insert temperature]o C

Therefore, the MRI related heating experiments for the titanium clip at 3 Tesla using a transmit/receive RF body coil at an MR system reported whole body averaged SAR of 2.9-W/kg (i.e., associated with a calorimetry measured whole body averaged value of 2.7-W/kg) indicated that the greatest amount of heating that occurred in associated with these specific conditions was equal to or less than + [insert temperature]o C after 15 minutes of continuous scanning.

Artifact Information

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the [implantable component]. Therefore, optimization of MR imaging parameters to compensate for the presence of this [implantable component] may be necessary.

Product FamilyImplantable ComponentHighest Temperature ChangeWhole Body Average Temperature Change
Stat TackTitanium Tack1.5°C1.8°C
TackerTitanium Tack1.5°C1.8°C
ProtackTitanium Tack1.5°C1.8°C
Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size168 mm2111 mm2298 mm2298 mm2
Plane OrientationParallelPerpendicularParallelPerpendicular
Product FamilyImplantable ComponentHighest Temperature ChangeWhole Body Average Temperature Change
ChemositeTitanium Port1.6°C1.8°C
Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size1,211 mm2975 mm22,405 mm21,839 mm2
Plane OrientationParallelPerpendicularParallelPerpendicular
Product FamilyImplantable ComponentHighest Temperature ChangeWhole Body Average Temperature Change
Steel SutureStainless Steel Suture1.8°C1.8°C
Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size551 mm2523 mm21568 mm2786 mm2
Plane OrientationParallelPerpendicularParallelPerpendicular

Please note that this does not apply to the following:

  1. Stainless steel staples/sutures or other stainless steel items that may have a greater mass than the current Covidien stainless steel staples/sutures.
  2. Exposure to static fields greater than 3.0 Tesla
  3. Use of magnetic materials such as suture needles
  4. Items not manufactured or distributed by Covidien
  5. FlexonTM Cardiac Pacing Leads

Do not perform magnetic resonance procedures if tissue integrity and implant’s ability to remain properly attached are of concern, or if proper identification of the implant location cannot be obtained.

Should you have any further questions, please contact our Technical Services group Sr. Quality Supervisor at 203-492-5548, or nicole.grant@medtronic.com.

PTFE Information Letter

To whom it may concern:

Some of our customers have expressed concern over a white powder residue sometimes seen on various Covidien products. This is the result of a lubrication process in which the device may be dipped or sprayed with a Polytetraflouroethylene (PTFE) solution. Once dried, the PTFE remains on the assembly, and may leave a small amount of white powder residue. This PTFE lubricant aids the proper functioning of the device.

PTFE is well characterized, having been used in implantation since the 1950’s. It has been implanted in many patients, with some implant durations going well beyond 20 years. PTFE is inert and is encapsulated by the body.

The following are some examples of long-term implant devices containing Teflon (PTFE);

  • Cardiac Valves
  • Catheter Material
  • Craniomaxillofacial Reconstruction Material
  • Abdominal Wall Mesh
  • Vascular Grafts
  • Pledgets

While there have been some inquiries about the appearance of the lubricant residue, there have been no confirmed patient injuries or device failures related to it.

Furthermore, the following biocompatibility tests have been performed by Covidien on Polytetraflouroethylene (PTFE) with acceptable results:

  • Cytotoxicity
  • Acute Systemic Toxicity
  • Hemolysis
  • Thrombogenicity
  • Pyrogenicity
  • Sensitivity
  • Vaginal Irritation
  • Mutagenicity
  • 7, 30, 60, 90 and 173 day implants
  • Intracutaneous Irritation

We hope this information addresses your concerns, and thank you for your input.

Sincerely,

Michael Ball 
Director, Biological Services 
Covidien 

Medtronic Minimally Invasive Therapies Metallic Staple Composition Notification

In response to inquiries concerning possible allergic reactions to the staples and clips in Medtronic Minimally Invasive Therapies (formerly known as Surgical Solutions, Covidien) devices, the following information applies.

The composition of Minimally Invasive Therapies titanium and stainless steel clips and staples is:

TitaniumStainless Steel
Nitrogen0.03% Carbon 0.03%
Carbon 0.08%Chrome 16.0 – 18.0%
Hydrogen 0.015%Nickel 10.0 – 14.0%
Iron 0.20%Manganese 2.0%
Oxygen 0.18%Silicon 1.0%
Titanium BalanceSulfur 0.03%
Phosphorus 0.045%
Molybdenum 2.0 – 3.0%
Iron Balance

Minimally Invasive Therapies implantable titanium staples and clips are composed of titanium per ASTM F67 Grade 1.The above titanium composition does not apply to the implantable titanium components in the following devices due to the use of a titanium alloy instead:

  1. Titanium Tackers (ProTack™, Stat Tack™, Tacker™)
  2. Herculon™
  3. Ogden™

The above titanium composition also does not apply to the implantable titanium components in the following device due to the use of titanium per ASTM F67 Grade 2 instead:

  1. ChemoSite™

The following devices apply stainless steel staples or clips:

  1. Premium GIA™ 50 & 90 Single Use Loading Units,
  2. PI™ Single Use Loading Units,
  3. LDS™ 15L Single Use Loading Unit,
  4. Royal™, Concord™, SM™, Signet™, MultiFire Premium™, DFS™, and Appose™ Skin Staplers.

Biocompatibility testing has been performed to a level appropriate for permanent implant on both titanium and stainless steel with no adverse effects noted, and there is a long history of safety and efficacy for both materials as implants.

Many of our devices contain stainless steel components that may have short term patient contact during a procedure. All of these components (such as anvils, jaws, shafts and blades) have been tested for short term contact indicative of use during a procedure.

Depending on the type of stainless steel used in these components, the nickel content may be up to 18% by weight.

If a patient presents concerns about metal allergies, the appropriate allergy screenings may be indicated. Please note that the above information does not, and that Minimally Invasive Therapies cannot, state, indicate, or imply that Minimally Invasive Therapies staples or clips will not induce some type of reaction in any particular patient.

We hope this information addresses your concerns.

Should you have any further questions, please contact our Technical Services group Sr. Quality Supervisor at 203-492-5548 or Nicole.Grant@Medtronic.com.

Teflon White Powder Residue Product Notification

To whom it may concern:

Some of our customers have expressed concern over a white powder residue sometimes seen on various Covidien products (formerly known as United States Surgical, a division of Tyco Healthcare Group, LP) including TA*, LDS*, EEA*, Surgiclip*, GIA*, ILA*, PI*, Premium*, Concorde*, Signet*, Appose*, SM*, DFS*, Tacker*, Absorbable stapling devices and all Endo stapling devices. This is the result of a lubrication process in which the device may be dipped or sprayed with a Polytetraflouroethylene (PTFE) solution. Once dried, the PTFE remains on the assembly, and may leave a small amount of white powder residue. This PTFE lubricant aids the proper functioning of the device.

PTFE is well characterized, having been used in implantation since the 1950’s. It has been implanted in many patients, with some implant durations going well beyond 20 years. PTFE is inert and is encapsulated by the body.

The following are some examples of long-term implant devices containing Teflon (PTFE);

Cardiac ValvesCatheter MaterialCraniomaxillofacial Reconstruction Material
Abdominal Wall MeshVascular GraftsPledgets

While there have been some inquiries about the appearance of the lubricant residue, there have been no confirmed patient injuries or device failures related to it.

Furthermore, there have been no patient injuries or patient complaints related to the white lubricant powder since the inception of the devices for greater than 20 years. There have been some documented visual complaints from some surgeons and nurses regarding the white lubricant powder.

An example would be from the Surgiclip* product line where at least 500,000 devices have been manufactured annually over those 20 years. That is over 10 million devices. This year alone it is estimated that we will make over 700,000 Premium Surgiclips*.

The following biocompatibility tests have been performed by Covidien on Polytetraflouroethylene (PTFE) with acceptable results:

Cytotoxicity     
Acute Systemic Toxicity     
Hemolysis     
Thrombogenicity     
Pyrogenicity    
Sensitivity     
Vaginal Irritation     
Mutagenicity      
7, 30, 60, 90 and 173 day implants    
Intracutaneous Irritation

We hope this information addresses your concerns.

Should you have any further questions, please contact our Biological Services group Sr. Biological Engineer at 203-492-5548, or Nicole.Grant@Covidien.com.