BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TRI-LOBE BALLOON CATHETER

    MDR report key: 2986095 · Received February 20, 2013

    Report

    Report Number
    3007284313-2013-00004
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    DQY
    PMA / PMN Number
    K081799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. REFER TO THE FOLLOWING MEDWATCH NUMBER FOR THE MEDWATCH ON THE GORE TAG THORACIC ENDOPROSTHESIS: 2017233-2013-00082.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WITH A COMFORTABLE GORE TAG THORACIC ENDOPROSTHESIS. DURING BALLOONING OF THE PROXIMAL END OF THE DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND ANGIOGRAPHY SHOWED A RUPTURED AORTA PROXIMAL TO THE DEVICE. THE BALLOON WAS REPORTEDLY INFLATED ACCORDING TO THE INSTRUCTIONS FOR USE. IT WAS ALSO REPORTED THE PATIENT'S AORTA WAS ATHEROSCLEROTIC ALONG THE ENTIRE DESCENDING THORACIC AORTA WITH CALCIFICATION AT THE IMPLANT SITE, AND THIS CONTRIBUTED TO THE AORTIC RUPTURE. AN ADDITIONAL DEVICE WAS PLACED DISTAL TO THE SUBCLAVIAN ARTERY TO COVER THE RUPTURE. HOWEVER, THE PATIENT WAS NOT ABLE TO REGAIN BLOOD PRESSURE AND EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72949 GORE TRI-LOBE BALLOON CATHETER DQY W. L. GORE ASSOCIATES 10695136

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R SIMBALTA| ALLEGRA| VICODIN| LISINOPRIL| LEVOTHYROXINE