BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 1884610 · Received October 19, 2010

    Report

    Report Number
    2953200-2010-02004
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (PROXIMAL PLACEMENT OF THE BARE SPRINGS OF THE STENT GRAFT CROSSING THE INNOMINATE ARTERY). CONCLUSIONS: (PROXIMAL PLACEMENT OF THE BARE SPRINGS OF THE STENT GRAFT CROSSING THE INNOMINATE ARTERY).

    Description of Event or Problem · 1

    A MEDTRONIC STENT GRAFT SYSTEM WHICH IS NOT APPROVED IN THE UNITED STATES WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF THE DISTAL AORTIC ARCH. IT WAS REPORTED THAT AFTER PERFORMING A CAROTID-CAROTID BYPASS, THE STENT GRAFT WAS PLACED PROXIMALLY WITH THE BARE SPRINGS CROSSING THE INNOMINATE ARTERY. A RELIANT BALLOON WAS THEN USED TO MODEL THE STENT GRAFT. THE RELIANT BALLOON WAS DISCARDED BY THE USER FACILITY. AT SOME TIME POST-OPERATIVELY, A TYPE A DISSECTION WAS OBSERVED. AT AN INTERVENTION FOR THE DISSECTION, A TEAR AT THE LEVEL OF THE BARE SPRINGS WAS NOTED. DETAILS ON THE INTERVENTION HAVE NOT BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY MEDTRONIC CARDIOVASCULAR GALWAY NA 0001093239

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention