BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2122958 · Received June 7, 2011

    Report

    Report Number
    2017233-2011-00266
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    January 18, 2011
    Report Date
    June 6, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIABAHN DEVICE REMAINS IMPLANTED AND IS FUNCTIONING AS INTENDED. A REVIEW OF THE MFG RECORDS WAS CONDUCTED. THE REVIEW OF THE MFG RECORDS VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE PT HAS FULLY RECOVERED AND IS DOING FINE.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A SUBCLAVIAN ARTERY PSEUDOANEURYSM OF 12 CM SIZE AFTER FRACTURE OF THE CLAVICLE SEVERAL YEARS AGO. THE PSEUDOANEURYSM WAS SLOW GROWING AND HAD STARTED TO COMPRESS THE TRACHEA. A DECISION WAS MADE TO TREAT THE PSEUDOANEURYSM WITH A VIABAHN DEVICE. IT WAS IMPOSSIBLE TO ADVANCE THE GUIDEWIRE INTO THE AORTIC ARCH BY BRACHIAL APPROACH AS THE SUBCLAVIAN ARTERY WAS VERY TORTUOUS. THE GUIDEWIRE BECAME STUCK INSIDE THE PSEUDOANEURYSM SAC. BY FEMORAL ACCESS, A LONG INTRODUCER SHEATH WAS PLACED INTO THE BRACHIOCEPHALIC TRUNK. THE BRACHIOCEPHALIC TRUNK WAS VERY SHORT, MAKING IT DIFFICULT TO ACHIEVE A STABLE POSITIONING OF THE SHEATH. ANOTHER GUIDEWIRE WAS INTRODUCED THROUGH THIS SHEATH REACHING THE ANEURYSMAL SAC. A GOOSE NECK SNARE WAS ADVANCED, AND THE BRACHIAL GUIDEWIRE WAS CAPTURED WITH THE SNARE WITHIN THE ANEURYSMAL SAC AND BROUGHT OUT THROUGH THE FEMORAL SHEATH. AN 8X10 VIABAHN DEVICE WAS ADVANCED THROUGH THE BRACHIAL SHEATH OVER THE BRACHIAL WIRE, POSITIONED AND DEPLOYED AT THE TARGET SITE. TOTAL EXCLUSION OF THE ANEURYSM WAS ACHIEVED. DURING WITHDRAWAL OF THE VIABAHN CATHETER, THE DISTAL CATHETER (OLIVE) BECAME STUCK IN THE ANGULATION OF THE ENDOPROSTHESIS. THE PHYSICIAN WAS UNABLE TO REMOVE THE DELIVERY CATHETER THROUGH THE BRACHIAL ACCESS SITE. THUS, THE DELIVERY CATHETER PORTS WERE CUT OFF THE CATHETER, AND THE CATHETER WAS REMOVED THROUGH THE FEMORAL SHEATH. THE VIABAHN ENDOPROSTHESIS REMAINS IMPLANTED. THE DELIVERY CATHETER WAS DISCARDED AT THE HOSP. THE PT SUFFERED A CVA IN THE RIGHT HEMISPHERE PEROP PROBABLY AS A RESULT OF THE MANIPULATIONS IN THE AORTIC ARCH. THE PT RECOVERED FULLY AND IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335 7488892

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other