BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT

    MDR report key: 23871857 · Received December 22, 2025

    Report

    Report Number
    3003910212-2025-01631
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    October 17, 2023
    Report Date
    December 22, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    FTM
    PMA / PMN Number
    K030782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - A4: AGE, GENDER, AND WEIGHT WERE REQUESTED, BUT NOT PROVIDED. B3: DATE OF EVENT WAS REQUESTED, BUT NOT PROVIDED, THEREFORE THE DATE THE ARTICLE WAS PUBLISHED (OCT. 17TH, 2023) WILL BE USED. H3: REVIEW OF THE MANUFACTURING RECORDS AND ENGINEERING EVALUATION COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO GORE. H6 - CODE B13: ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED FROM THE AUTHOR, BUT NO RESPONSE WAS RECEIVED. 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.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿LONG-TERM OUTCOMES OF LAPAROSCOPIC SLEEVE GASTRECTOMY AS A REVISIONAL PROCEDURE FOLLOWING ADJUSTABLE GASTRIC BANDING: VARIATIONS IN OUTCOMES BASED ON INDICATION¿ THE ARTICLE WAS PUBLISHED ONLINE OCTOBER 17TH, 2023. OBESITY SURGERY (2023) 33:3722¿3739 HTTPS://DOI.ORG/10.1007/S11695-023-06886-8. THE ARTICLE MENTIONS STAPLE LINE LEAKS THAT REQUIRED REINTERVENTION FOR THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT. THERE WERE TWO TYPES OF STAPLE LINE BUTTRESSING USED DURING THE SURGERIES: SEAMGUARD AND TRI-STAPLE 2.0 BY COVIDIEN/MEDTRONIC. THE ARTICLE DOES NOT MENTION WHICH PRODUCT WAS USED IN THE PATIENTS WHO REQUIRED REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621893 GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MESH, SURGICAL FTM W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R| O