BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1130445 · Received August 19, 2008

    Report

    Report Number
    2017233-2008-00471
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    AN ABSTRACT REVIEW INDICATED THAT IN 2007, A HIGH SPEED MVA PATIENT SUSTAINED MULTIPLE INJURIES INCLUDING A TEAR AND A PSEUDOANEURYSM ALONG THE COMMON CAROTID -INNOMINATE (CCI). A VIABAHN ENDOPROSTHESIS WAS PLACED; HOWEVER, IT MIGRATED TO THE LEVEL OF THE SMA/RENAL ARTERY AND WAS FREE FLOATING. A CATHETER WAS USED TO MOVE THE ENDOPROSTHESIS TO THE LEFT COMMON ILLIAC PROXIMAL TO THE INTERNAL ILIAC ARTERY WITHOUT CONSEQUENCE. A SECOND VIABAHN DEVICE WAS DEPLOYED ACROSS THE CCI PSEUDOANEURYSM. AGAIN, THE DEVICE MIGRATED TO THE SAME LOCATION AND WAS MOVED VIA CATHETER DISTALLY TO THE RIGHT COMMON ILIAC ARTERY. THE CASE WAS TERMINATED AND A REINTERVENTION WAS PERFORMED TWO DAYS LATER WITH PLACEMENT OF AN ATRIUM COVERED STENT. WHICH EXCLUDED THE CCI PSEUDOANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. FURTHER INVESTIGATION IS PENDING. "STENT MIGRATION DURING ENDOVASCULAR REPAIR OF A TRAUMATIC PSEUDOANEURYSM OF THE INNOMINATE-CAROTID ARTERY BIFURCATION," BURKETT AB, KOCHOPURA P, WELLONS ED, ROSENTHAL D). 32ND ANNUAL MEETING OF THE SOUTHERN ASSOCIATION FOR VASCULAR SURGERY (SAVS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES WLG335 04437140

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention