BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TRI-LOBE BALLOON CATHETER

    MDR report key: 1060867 · Received June 13, 2008

    Report

    Report Number
    2017233-2008-00331
    Event Type
    Death
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR OF THE DESCENDING THORACIC AORTA. THE GORE TAG THORACIC ENDOPROSTHESIS DEPLOYED WITHOUT INCIDENT. FOLLOWING DEPLOYMENT, A GORE TRI-LOBE BALLOON WAS ADVANCED WITHOUT THE USE OF FLUOROSCOPY. AFTER THE BALLOON HAD BEEN ADVANCED, FLUOROSCOPY WAS TURNED ON, AND THE BALLOON WAS VISUALIZED IN THE ASCENDING AORTA. THE WIRE AND BALLOON CATHETER WERE MANIPULATED, WHICH RESULTED IN PATIENT DISTRESS. A PERICARDIAL WINDOW WAS PERFORMED AND BLOOD WAS EVACUATED FROM THE THORACIC CAVITY IN ORDER TO STABILIZE THE PATIENT. ANGIOGRAPHY DEMONSTRATED CONTRAST OUTSIDE THE AORTA, IN BETWEEN THE DESCENDING AORTA AND THE HEART. CARDIAC SURGEONS PROCEEDED TO REPAIR THE VESSELS. THE PATIENT DIED DURING THE NIGHT. THE PHYSICIAN REPORTED THE ASCENDING AORTA WAS PERFORATED BY THE BALLOON CATHETER. THE PHYSICIAN STATED THAT THIS EVENT WAS CAUSED BY OPERATOR ERROR AND WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TRI-LOBE BALLOON CATHETER NONE DQY W.L. GORE & ASSOCIATES,INC WLG360 05876362

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death