BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1162269 · Received September 5, 2008

    Report

    Report Number
    2017233-2008-00580
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 5, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORDS WERE REVIEWED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT, THIS DEVICE WAS PART OF VERIFIED THAT THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE DEVICE WAS RETURNED AND INSPECTED. THE EXAMINATION FOUND NO ANOMALIES ATTRIBUTABLE TO THE MANUFACTURED DEVICE. BASED ON THE CLINICAL INFORMATION RECEIVED AND THE EXAMINATION OF THE RETURNED PRODUCT, IT APPEARS THAT THE LESION WAS PRE-DILATED WITH AN INADEQUATE SIZE BALLOON. THE INSTRUCTION FOR USE RECOMMEND USE OF A 6 MM BALLOON FOR DILATION WHEN USING A 6MM DEVICE (SEE SIZING TABLE). IN ADDITION, THE DEPLOYMENT LINE MAY HAVE BECOME STUCK / HUNG-UP ON PROTRUSIONS WITHIN THE VESSEL, SUCH AS CALCIUM DEPOSITS, ULTIMATELY LEADING TO DEPLOYMENT LINE BREAK.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A VERY CALCIFIED OCCLUSION OF THE SFA. THE LESION WAS PRE-DILATED WITH A 5MM BALLOON. THE VIABAHN DEVICE WAS POSITIONED JUST DISTAL TO HUNTER'S CANAL. WHILE PULLING THE DEPLOYMENT KNOB, THE VIABAHN DEVICE OPENED 1/2 WAY WHEN THE DEPLOYMENT LINE BROKE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE HALF DEPLOYED DEVICE. THE PROCEDURE WAS COMPLETED IMPLANTING ANOTHER VIABAHN DEVICE WITHOUT ANY ADVERSE OUTCOME FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335 05779831

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR