BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 3021077 · Received March 13, 2013

    Report

    Report Number
    2017233-2013-00142
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 13, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    TWO GORE VIABAHN ENDOPROSTHESES ALONG WITH AN EXCLUDER DEVICE WERE USED IN A "CHIMNEY" PROCEDURE. THE EXCLUDER WAS POSITIONED BELOW THE RENALS AND THE VIABAHNS WERE POSITIONED TO MAINTAIN FLOW TO THE RENAL ARTERIES. AFTER SIMULTANEOUS DEPLOYMENT OF BOTH VIABAHNS AND THE EXCLUDER, KISSING BALLOONS WERE USED TO POST DILATE THE DEVICES. THE POSITIONING OF THE DEVICES WAS CORRECT. IT WAS REPORTED TO GORE THAT AFTER THE GATE CANNULATION AND THE CONTRALATERAL LEG DEPLOYMENT, ANGIOGRAPHIC IMAGES SHOWED THAT THE MAIN BODY OF THE EXCLUDER DEVICE HAD MIGRATED APPROXIMATELY 2 CM. THE MIGRATION CAUSED AN IMPAIRMENT OF THE BLOOD FLOW TO THE RENAL ARTERIES. AN OPEN REPAIR SURGERY WAS PERFORMED AND THE EXCLUDER AND THE VIABAHN DEVICES WERE REMOVED. THE PATIENT IS IN GOOD CONDITION WITH NO RENAL IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106427 GORE VIABAHN ENDOPROSTHESIS NIP/STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 10626108

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention AORTIC EXCLUDER AAA ENDOPROSTHESES LOTS:| 9752298 AND 9969239| VIABAHN LOT NUMBER 8250813