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

Model Number 1320030020

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Hernia (2240)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

It should be noted that the gore-tex® soft tissue patch instructions for use 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 instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".

Event Description

It was reported to gore that the patient underwent open diaphragmatic hernia repair on (b)(6) 2014 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, infected mesh, bowel perforation, mesh migration, abscess, mesh erosion, removal of infected mesh and adhesions.Additional event specific information was not provided.

Manufacturer Narrative

D4: changed device information to unk.H6: conclusion code remains unchanged.

Manufacturer Narrative

Retracting all medwatches associated with this report number as this was found to be a duplicate device.This event was captured previously under medwatch 3003910212-2021-01182.

• Brand Name: GORE-TEX® SOFT TISSUE PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: heidi womble ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11564188
• MDR Text Key: 244384979
• Report Number: 3003910212-2021-01184
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600533
• UDI-Public: 00733132600533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 1320030020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG