BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2123499 · Received June 8, 2011

    Report

    Report Number
    2017233-2011-00270
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 8, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 VIABAHN DEVICE WAS RETURNED AND INSPECTED. THE EXAMINATION CONFIRMED THAT THE ENDOPROSTHESIS WAS PARTIALLY EXPANDED APPROX 1 CM. THE DEPLOYMENT LINE WAS BROKEN AT DISTAL END OF CONSTRAINED PORTION OF THE ENDOPROSTHESIS. THE ENDOPROSTHESIS WAS SHIFTED DISTALLY APPROX 1 CM ON THE DISTAL SHAFT, LIKELY DUE TO WITHDRAWAL THROUGH THE SHEATH. WE WERE UNABLE TO DETERMINE THE EXACT CAUSE(S) FOR THE DEPLOYMENT LINE BREAK IN-VIVO.

    Description of Event or Problem · 1

    WHILE PERFORMING A VORTEC (DEBRANCHING) PROCEDURE, THE PHYSICIAN DECIDED TO REVASCULARIZE THE RIGHT RENAL ARTERY WITH A VIABAHN DEVICE. HE CANNULATED THE VESSEL, PLACED AN 8 FR CORDIS INTRODUCER SHEATH AND CHANGED TO A STIFF AMPLATZ GUIDEWIRE. A 9X5 VIABAHN DEVICE WAS ADVANCED AND POSITIONED AT THE TARGET SITE. THE PHYSICIAN UNSCREWED THE DEPLOYMENT KNOB AND STARTED TO PULL ON THE LINE, BUT THE DEPLOYMENT LINE BROKE. THE VIABAHN ENDOPROSTHESIS OPENED LESS THAN 1 CM AT THE DISTAL END. THE PHYSICIAN WAS ABLE TO PULL THE DELIVERY CATHETER WITH THE VIABAHN DEVICE BACK THROUGH THE SHEATH WITHOUT ANY INCIDENT. THE PROCEDURE WAS COMPLETED IMPLANTING ANOTHER 9X5 VIABAHN WITHOUT ANY ADVERSE OUTCOME FOR THE PT.

    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 8374069

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR