BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 935067 · Received October 29, 2007

    Report

    Report Number
    2017233-2007-00351
    Event Type
    Injury
    Date Received
    October 29, 2007
    Report Date
    October 29, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NIP
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND FUNCTIONING AS INTENDED. NO LOT NUMBERS HAS BEEN IDENTIFIED. THE INVESTIGATION IS PRESENTLY IN PROGRESS. ARTICLE IN, "SEMINARS IN INTERVENTIONAL RADIOLOGY" 2007; 24(3):307-311 ACUTE COMPARTMENT SYNDROME RELATED TO STENT-GRAFT EXCLUSION OF A POPLITEAL ARTERIAL ANEURYSM. AUTHORS: MILLER MJ JR, STIRLING MJ, CHANG YH, SMITH TP.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A LEFT POPLITEAL ANEURYSM. DURING DEPLOYMENT, THE DEVICE BEGAN TO BOW WHICH RESULTED IN THE PROXIMAL MIGRATION OF THE DEVICE. IN AN ATTEMPT TO MINIMIZE THE BOWING, THE GUIDEWIRE WAS ADVANCED FURTHER AND OUT OF THE FLUOROSCOPIC FIELD OF VIEW. FOLLOWING DEPLOYMENT OF THE FIRST DEVICE, THE DISTAL GUIDEWIRE TIP WAS NOTED TO BE IN A SMALL BRANCH OF PRESUMABLY THE POSTERIOR TIBIAL ARTERY. THE WIRE WAS REPOSITIONED AND TWO ADDITIONAL DEVICES WERE DEPLOYED. FOLLOWING RELEASE OF THE THIRD STENT GRAFT, THE PATIENT COMPLAINED OF MILD TIGHTNESS IN HIS CALF. ANGIOGRAPHY DEMONSTRATED EXCLUSION OF THE ANEURYSMAL SEGMENT OF THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES AND A FOCAL AREA OF EXTRAVASATION FROM A BRANCH ARISING FROM THE POSTERIOR TIBIAL ARTERY WHERE THE GUIDEWIRE HAD PREVIOUSLY BEEN PLACED. COIL EMBOLIZATION WAS PERFORMED TO THE POSTERIOR TIBIAL ARTERY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT IN STABLE CONDITION. APPROXIMATELY 3 HOURS FOLLOWING THE PROCEDURE, THE PAIN WORSENED. PHYSICAL EXAM AND DIAGNOSTICS CONFIRMED COMPARTMENT SYNDROME OF ALL FOUR COMPARTMENTS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A FASCIOTOMY WAS PERFORMED. THE PATIENT'S PAIN IMPROVED, WITH NO EVIDENCE OF SENSORY LOSS OR MOTOR WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS PERIPHERAL ENDOVASCULAR STENT GRAFT NIP W.L. GORE & ASSOCIATES,INC WLG335

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention