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

Catalog Number	1410015010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); No Code Available (3191)
Date of Event	10/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The initial reporter's complete address is (b)(6).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.
Event or Problem Description
It was reported to gore that the patient underwent laparoscopic paraoesophageal hernia repair on (b)(6) 2018 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: surgery to remove mesh, hernia recurrence, mesh material found in esophagus.Additional event specific information was not provided.
Additional Manufacturer Narrative
H6: updated results code.Conclusion code remains unchanged.
Additional Manufacturer Narrative
H6: code 4316 (appropriate term/code not available) is being used for: duplicate complaint.See mfr report#: 3003910212-2019-00267.

• Brand Name: GORE-TEX® SOFT TISSUE PATCH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9417526
• Report Number: 3003910212-2019-00500
• Device Sequence Number: 2579763
• Product Code: FTL
• UDI-Device Identifier: 00733132600595
• UDI-Public: 00733132600595
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K963619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 1410015010
• Device Lot Number: 15274409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/02/2020; 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100