BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 11247655 · Received January 28, 2021

    Report

    Report Number
    3003910212-2021-01162
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    January 5, 2021
    Report Date
    July 21, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GAW
    UDI-DI
    00733132603138
    PMA / PMN Number
    P820083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4: ADDED PMA/510(K)NUMBER P820083.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED TO GORE, THEREFORE AN ENGINEERING EVALUATION COULD NOT BE PERFORMED. PER THE INSTRUCTIONS FOR USE (IFU) FOR THE MISUSE OF THIS SUTURE, LIKE ANY OTHER SUTURE, CAN RESULT IN SEVERE INJURY OR DEATH TO THE PATIENT. AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE WITH SURGICAL INSTRUMENTS OR EXPOSING THE SUTURE TO SHARP EDGES. IN ORDER TO MINIMIZE NEEDLE DAMAGE, DO NOT DRIVE THE NEEDLE FROM THE CHANNEL WHERE THE SUTURE IS ATTACHED. NEEDLES ARE NOT INTENDED TO BE IMPLANTED. AT LEAST SEVEN, EQUALLY TENSIONED, FLAT SQUARE THROWS ARE REQUIRED TO PRODUCE A SECURE KNOT WHEN TYING GORE-TEX® SUTURE. ADDITIONAL THROWS MAY BE NECESSARY DEPENDING ON SURGICAL CIRCUMSTANCES. WHEN TYING KNOTS WITH THE GORE-TEX® SUTURE, TENSION SHOULD BE APPLIED BY PULLING EACH STRAND OF THE SUTURE IN OPPOSITE DIRECTIONS WITH EQUAL FORCE. AS THE KNOT IS TENSIONED, THE AIR IN THE SUTURE IS FORCED OUT. CARE SHOULD BE TAKEN TO AVOID USING A JERKING MOTION WHICH COULD BREAK THE SUTURE. UNEVEN TENSIONING OF A WELL FORMED SQUARE KNOT MAY RESULT IN AN UNSECURE KNOT. WHEN THE GORE-TEX® SUTURE IS PROPERLY TENSIONED AND FORMED, STANDARD SURGICAL KNOTTING TECHNIQUES WILL PRODUCE A SECURE KNOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE BY THE PRODUCT SPECIALIST THAT ON (B)(6) 2020 A BREAST REDUCTION MAMMAPLASTY AND AREOLA RECONSTRUCTION WAS PERFORMED ON THE BREAST USING THE 4U16A GORE-TEX® SUTURE. THE NEEDLES WERE REMOVED AND THE SUTURE WAS ATTACHED TO A KEITH NEEDLE FOR THE PROCEDURE. ON (B)(6) 2021 THE PHYSICIAN OBSERVED THAT THE SUTURE HAD BROKEN. IT WAS REPORTED THE PATIENT WILL RETURN FOR A RE-OPERATION, BUT A DATE HAS NOT BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144396 GORE-TEX SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW W. L. GORE & ASSOCIATES, INC. 4U16A 00733132603138

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| O