BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2012859 · Received March 1, 2011

    Report

    Report Number
    2017233-2011-00095
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    October 27, 2010
    Report Date
    March 1, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. ANGIOGRAPHIC IMAGES WERE RETURNED AND EVALUATED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE REVIEW OF ANGIOGRAPHIC IMAGES CONFIRMED THE DEVICE MIGRATION. CONTRAST APPEARED BE SURROUNDING THE PROXIMAL END OF THE IMPLANTED STENT. THE DEVICE DOES NOT APPEAR TO BE TOUCHING VESSEL WALL. BASED ON THE EVALUATION OF THE IMAGES, IT APPEARS, THE DEVICE MAY HAVE BEEN UNDERSIZED. UNDERSIZING OF THE DEVICE MAY HAVE CONTRIBUTED TO THE DEVICE MIGRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A (B)(6) DIALYSIS PATIENT RECEIVED A GORE VIABAHN ENDOPROSTHESIS FOR THE TREATMENT OF A RECURRENT STENOSIS OF THE ANASTOMOSIS AND PROXIMAL VEIN WITH A PSEUDOANEURYSM OF THE PROXIMAL VEIN. FOLLOWING THE PLACEMENT OF THE VIABAHN DEVICE, THE POST PLACEMENT ANGIOGRAM REVEALED A WIDE-OPEN PROXIMAL VEIN AND THE FULL EXCLUSION OF THE PSEUDOANEURYSM. THE PATIENT RETURNED IN (B)(6) 2010 WITH DECREASED TRANSSONIC FLOW AND THE VIABAHN DEVICE HAD MIGRATED UP INTO THE CEPHALIC ARCH LODGING AT A BIFURCATION AND OBSTRUCTING THE FLOW. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED AT THAT TIME WITH NO IMPROVEMENT NOTED. THE PATIENT RETURNED ON (B)(6) 2011, AND HAD THROMBOSED THE COLLATERAL VEIN THAT HAD FORMED BETWEEN THE CEPHALIC AND AXILLARY VEIN AND HAD A LOT OF COLLATERALS IN THE CEPHALIC WITH A COMPLETE OBSTRUCTION OF THE CEPHALIC. THE PATIENT IS SCHEDULED TO HAVE A CATHETER PLACED AND A NEW FISTULA.

    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 WLG335 05766760

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR