BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 1624465 · Received March 4, 2010

    Report

    Report Number
    2017233-2010-00107
    Event Type
    Injury
    Date Received
    March 4, 2010
    Date of Event
    January 13, 2010
    Report Date
    March 4, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYF
    PMA / PMN Number
    K903931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET COMPLETED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A GORE-TEX STRETCH VASCULAR GRAFT (TAPERED) WAS IMPLANTED IN PATIENT FOR A-V ACCESS IN THE RIGHT ARM FROM THE BRACHIAL ARTERY TO THE AXILLARY VEIN. THE PATIENT WAS STARTED ON ANTICOAGULATION POST-OP DUE TO MULTIPLE PREVIOUS EARLY ACCESS FAILURES. IT WAS REPORTED THAT APPROXIMATELY 36 HOURS POST-OP, THE PATIENT COMPLAINED OF NUMBNESS IN HER HAND AND WAS NOTED TO HAVE AN EXPANDING HEMATOMA IN HER RIGHT AXILLA. PATIENT WAS TAKEN URGENTLY TO THE OPERATING ROOM. UPON EXPLORING THE AXILLARY WOUND, A LARGE AMOUNT OF SEROUS FLUID WAS EVACUATED. NO SIGNIFICANT HEMATOMA WAS EVACUATED. THERE APPEARED TO BE WEEPING OF SEROUS FLUID (SEROMA) FROM THE GRAFT. THE GRAFT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX STRETCH VASCULAR GRAFT DYF/PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM DIAMETER DYF W.L. GORE & ASSOCIATES WLG212 06818980

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention