MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® PREPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC

Model Number GKWV1015

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

It should be noted that the gore® synecor preperitoneal biomaterial 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® synecor preperitoneal biomaterial 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 ventral/incisional hernia repair on (b)(6) 2018 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: foreign body giant cell reaction, mesh detachment, infection, hernia recurrence, surgery to remove mesh, and severe and chronic pain/discomfort. Additional event specific information was not provided.

• Brand Name: GORE® SYNECOR® PREPERITONEAL BIOMATERIAL
• 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12509519
• MDR Text Key: 272751188
• Report Number: 3003910212-2021-01290
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163576
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/05/2020
• Device Model Number: GKWV1015
• Device Catalogue Number: GKWV1015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/21/2021 Patient Sequence Number: 1