BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1101771 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00656
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (PENDING DEVICE RETURN FOR EVALUATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR TREATMENT OF A 7.8 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED DUE TO AORTIC NECK ANGULATION (MDR2953200-2008-006360). THE PHYSICIAN ATTEMPTED TO RESOLVE THE TYPE I ENDOLEAK BY PLACEMENT OF TWO ANEURX AORTIC CUFFS (MDR2953200-2008-00655) AND ONE TALENT AORTIC CUFF (2953200-20080-00656), HOWEVER, 5 DAYS LATER, THE ENDOLEAK DID NOT RESOLVE AND THE PT WAS CONVERTED TO AN OPEN REPAIR. THE PHYSICIAN SURGICALLY CONVERTED THE PT TO A CONVENTIONAL STENT. THE EXPLANTED STENT GRAFTS HAVE BEEN REC'D AND THE ANALYSIS IS PENDING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00112928

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention