BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT XCELERANT - HYDRO

    MDR report key: 1972379 · Received January 25, 2011

    Report

    Report Number
    2953200-2011-00164
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 26, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK. DISEASE PROGRESSION WITH AORTIC NECK DILATATION. CONCLUSION: DISEASE PROGRESSION WITH AORTIC NECK DILATATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM ABDOMINAL AORTIC ANEURYSM APPROX 21 MONTHS AGO. THERE WAS MODERATE TORTUOSITY, MILD CALCIFICATION; AORTIC NECK WAS SHORT IN LENGTH (1CM) AND DISEASE PROGRESSION WITH AORTIC NECK DILATATION. AT A ROUTINE FOLLOW- UP APPOINTMENT, THE CT DEMONSTRATED DISTAL STENT GRAFT MIGRATION OF 8 MM, WITH A TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED A TALENT CUFF; HOWEVER, THE ENDOLEAK DID NOT RESOLVE (MFR REPORT # 2953200-2011-00165). THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER'S STENT GRAFT AND THE ENDOLEAK RESOLVED. NO 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 XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00189895

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention