BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2801461 · Received October 10, 2012

    Report

    Report Number
    2017233-2012-00703
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    June 12, 2012
    Report Date
    September 10, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE STERILIZATION RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. REVIEW OF THE MFG RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A THROMBOSED ANEURYSM OF THE RIGHT ARTERIAL POPLITEA. THE GORE VIABAHN ENDOPROSTHESIS WAS IMPLANTED ON (B)(6) 2012 SHOWING GOOD FLOW W/O ANY RESTENOSIS. POST SURGERY THE PT EXPERIENCED PAIN IN THE HOLLOW OF THE KNEE WITH REGULAR NIGHT SWEATS. CT SCAN ON (B)(6) 2012 SHOWED LIQUID ACCUMULATION AROUND THE IMPLANTED DEVICE. THE GORE VIABAHN ENDOPROSTHESIS WAS REMOVED (B)(6) 2012 DURING A REVISION, WITH RESECTION OF THE PAA ANEURYSM. THE ABSCESS WAS EVACUATED AND AN INTERPOSITION 'SAPHENASEGMENT' WAS IMPLANTED. THERE WERE NO COMPLICATIONS POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NIP / STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 8574391

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention