BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE BIABAHN ENDOPROSTHESIS

    MDR report key: 3143051 · Received May 23, 2013

    Report

    Report Number
    2017233-2013-00335
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON EXAMINATION OF THE RETURNED DEVICE, IT COULD NOT BE DETERMINED IF THERE WERE ANOMALIES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICE. THE GORE VIABAHN ENDOPROSTHESIS INSTRUCTIONS FOR USE STATE: W.L. GORE AND ASSOCIATES HAS INSUFFICIENT CLINICAL AND EXPERIMENTAL DATA UPON WHICH TO BASE ANY CONCLUSIONS REGARDING THE EFFECTIVENESS OF THE GORE VIABAHN ENDOPROSTHESIS IN APPLICATIONS WHERE THE DEVICE IS DEPLOYED WITHIN STENTS OR STENT GRAFTS OTHER THAN THE GORE VIABAHN ENDOPROSTHESIS OR THE GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. OTHER DEVICES MAY INTERFERE WITH THE DEPLOYMENT OF THE GORE VIABAHN ENDOPROSTHESIS RESULTING IN DEPLOYMENT FAILURE OR OTHER DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED FOR AN INSTENT RE-STENOSIS CASE. THE GORE VIABAHN ENDOPROSTHESIS WAS ADVANCED INTO POSITION AND THE DEPLOYMENT LINE WAS PULLED. THE COMPLAINANT SUSPECTS THE DEPLOYMENT LINE SNAGGED ON A PREVIOUSLY IMPLANTED BARE METAL STENT WHEN THE DEPLOYMENT LINE BROKE. THE DEVICE WAS REMOVED. THE COMPLAINANT RE-BALLOONED THE AREA AND SUCCESSFULLY PLACED A 6X10 GORE VIABAHN ENDOPROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228213 GORE BIABAHN ENDOPROSTHESIS NIP W.L. GORE & ASSOCIATES,INC 10772848

    Patients

    Seq Age Sex Outcome Treatment
    1 Other