BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010844 · Received March 3, 2011

    Report

    Report Number
    2953200-2011-00587
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, SEVERELY ANGULATED NECK. EVALUATION, CONCLUSION: SEVERELY ANGULATED NECK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED APPROXIMATELY 2.5 MONTHS AGO, FOR A HIGH RISK PT, FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTA HAD A SHORT NECK WITH A 60-90 DEGREE ANGLE. VESSEL MORPHOLOGY INCLUDES HEAVY NECK AND BILATERAL ILIAC CALCIFICATION AND AN UNK AMOUNT OF THROMBUS. IT WAS REPORTED THAT THE PT WAS ADMITTED VERY SICK TO RECEIVE A LEFT VENTRICULAR ASSIST DEVICE WHEN THE 11 CM ABDOMINAL AORTIC ANEURYSM WAS DISCOVERED. DURING THE TEVAR PROCEDURE, A TYPE I ENDOLEAK APPEARED AND PERSISTED. THE PHYSICIAN PUT IN A TALENT CUFF AND A COMPETITOR'S STENT. A CONTRAST CT AFTER THE PROCEDURE SHOWED THAT THE TYPE I ENDOLEAK WAS RESOLVED. ONE MONTH AGO A PROXIMAL TYPE 1 ENDOLEAK WAS SEEN ON A CONTRAST CT. THE PT WAS NOT A SURGICAL CANDIDATE. TWO WEEKS AGO AN ADDITIONAL TEVAR WAS PERFORMED TO PLACE 2-36 MM CUFFS IN THE VERY ANGULATED NECK. A COMPETITOR'S BALLOON WAS USED. THE PHYSICIAN ASSESSED THAT THE LEAK WAS ANATOMY RELATED NOT DEVICE RELATED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. REF, MFR. 2953200-2001-00XXX AND 2953200-2001-00XXX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00333356

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention