MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT; MESH, SURGICAL

Catalog Number	12BSGEC60A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was requested, but not provided, therefore the date of the event will be when the information was received, january 4th, 2024.The instructions for use (ifu) for the gore® seamguard® bioabsorbable staple line reinforcement state: potential device or procedure-related adverse events possible adverse reactions and complications that may occur with the use of gore®seamguard® bioabsorbable staple line reinforcement or in any endoscopic surgical procedure and may require intervention include, but are not limited to: ¿ adhesions ¿ blood loss ¿ hematoma ¿ infection ¿inflammation ¿ leaks 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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 or Problem Description
It was reported, dr.(b)(6) has experienced three procedures recently where there was infection and abscess at the staple line.This is a complication he doesn't typically see with such frequency.This has led him to investigate potential sources of contamination, and/or rule out contributing factors.The procedures were all duodenal switches and gore® seamguard® bioabsorbable staple line reinforcement was used on the duodenal transection.Additional products used in the procedure include an ethicon stapler, and baxter peri-strips staple line reinforcement on the gastric pouch.It was reported there was a re-operation and no pre-existing infection in the location of the device or surrounding adjacent tissues.Reportedly, the color cartridge being used was white and the infection did occur at the anastomosis.It was reported the infection was treated with a reoperation and antibiotics.
Additional Manufacturer Narrative
B3 - date of adverse event - (b)(6) 2023.D6.A - implant date - (b)(6) 2023.The instructions for use (ifu) for the gore® seamguard® bioabsorbable staple line reinforcement state: potential device or procedure-related adverse events possible adverse reactions and complications that may occur with the use of gore®seamguard® bioabsorbable staple line reinforcement or in any endoscopic surgical procedure and may require intervention include, but are not limited to (shown in english alphabetical order): ¿ adhesions ¿ blood loss ¿ hematoma ¿ infection ¿inflammation ¿ leaks.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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.

• Brand Name: GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT
• Common Device Name: MESH, SURGICAL
• 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: angela brown ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18619012
• Report Number: 3003910212-2024-01538
• Device Sequence Number: 20684568
• Product Code: FTM
• UDI-Device Identifier: 00733132600342
• UDI-Public: 00733132600342
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K030782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 04/29/2026
• Device Catalogue Number: 12BSGEC60A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 102 KG