BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 2158098 · Received June 30, 2011

    Report

    Report Number
    2017233-2011-00328
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE INTERVENTION, BOTH DEVICES ARE FUNCTIONING AND REMAIN IMPLANTED. THE INVESTIGATION INTO THIS EVENT IS CURRENTLY IN PROCESS. PLEASE, NOTE: ONE ADDITIONAL VIABAHN DEVICE WAS INVOLVED IN THIS EVENT. MEDWATCH # 2017233-2011-00327 WAS SUBMITTED FOR DEVICE LOT # 8081265.

    Description of Event or Problem · 1

    TWO 9X15 VIABAHN DEVICES WERE IMPLANTED FOR TREATMENT OF A POPLITEAL ARTERY ANEURYSM. POST PROCEDURE, THERE WAS 1 MAJOR RUN-OFF VESSEL (ANTERIOR TIBIAL ARTERY). THE POSTERIOR TIBIAL ARTERY DIDN'T GO MUCH FURTHER. THE PERONEAL ARTERY WAS PATENT PROXIMALLY, SOME DISEASE AT THE POSTERIOR TIBIAL TRUNK. POST DISCHARGE, THE PT WAS PUT ON WARFARIN (NO CLOPIDOGREL) AND WAS ADVISED TO REST AND RECUPERATE. WITHIN (B)(6) POST PROCEDURE, THE PT BEGAN TO EXPERIENCE PAIN. AT (B)(6) CHECK-UP, THROMBUS WAS NOTED THROUGHOUT THE DEVICE. A THROMBECTOMY WAS PERFORMED, SURGICALLY OPENING THE POPLITEAL ARTERY DISTAL TO THE DEVICES AT NORMAL APPEARING VESSEL. THE PT WAS FINE AT THE END OF THE RE-INTERVENTION PROCEDURE AND THE DEVICE IS CURRENTLY PATENT. THE PHYSICIAN INDICATED THAT THE OCCLUSION OF THE VIABAHN DEVICES WAS NOT DEVICE-RELATED. HE FURTHER NOTED THAT THE RUN-OFF WAS LESS THAN IDEAL. ADDITIONALLY, HE SUGGESTED THAT MAYBE ASPIRIN SHOULD HAVE BEEN PRESCRIBED TO THE PT AT DISCHARGE AS WELL AS WARFARIN.

    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 8188727

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention