MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH; MESH, SURGICAL, POLYMERIC

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/10/1992

Event Type  Injury  

Manufacturer Narrative

Additionally, event information such as item/lot number, implant date, date of explant, patient medical history were requested, however no information has been received.According to the instructions for use (ifu) for gore-tex® soft tissue patch complications may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/re-intervention, fever and recurrence.

Event Description

The following literature article was reviewed, "reconstruction of the chest wall with e-ptfe following major resection." the article reports a chest wall reconstruction was performed with an expanded polytetrafluroethylene (e-ptfe) gore-tex® soft tissue patch (gore-tex)and vascularized flaps in all patients.The article reported perioperative antibiotics were used in all patients.The article reported reconstruction of the skeletal defect and stabilization of the chest wall was performed with a 2 mm gore-tex® soft tissue patch in all patients.The article reported during the perioperative period, none of the patients developed an infection of the gore-tex patch.However, 10 months postoperatively, one of the patients did develop a late infection involving the patch.The patch was easily removed.

Manufacturer Narrative

The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore-tex® soft tissue patch is provided sterile.Procedure and specific patient factors may contribute to or cause infection, leading to contamination or infection of the mesh material.The instructions for use further state: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following literature article was reviewed, "reconstruction of the chest wall with e-ptfe following major resection.The article reports a chest wall reconstruction was performed with an expanded polytetrafluorethylene (e-ptfe) gore-tex® soft tissue patch (gore-tex)and vascularized flaps in all patients.The article reported perioperative antibiotics were used in all patients.The article reported reconstruction of the skeletal defect and stabilization of the chest wall was performed with a 2 mm gore-tex® soft tissue patch in all patients.The article reported during the perioperative period, none of the patients developed an infection of the gore-tex patch.However, 10 months postoperatively, one of the patients did develop a late infection involving the patch.The patch was easily removed.The article further reports ¿prosthetic material has been advocated in the reconstruction of noncontaminated wounds.We believe that in contaminated wounds (i.E., ulceration and radiation necrosis), prosthetic material can be used, if necessary, only after the contaminated area has been completely excised back to viable tissue.This should not interfere with subsequent infection problems as evidenced by only one (delayed) infection in our series, despite five of our nine patients receiving radiation to the chest wall preoperatively.¿ authors concluded that ¿this study also demonstrates many of the advantages of e-ptfe as a chest wall substitute compared with other previously described prosthetic materials.The use of a gore-tex patch along with described flaps for soft tissue coverage provides good functional and aesthetic results.¿.

• Brand Name: GORE-TEX SOFT TISSUE PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9649312
• MDR Text Key: 189353970
• Report Number: 3003910212-2020-00013
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K963619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other