BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 1943761 · Received December 21, 2010

    Report

    Report Number
    2953200-2010-02591
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: (TORTUOUS AORTA, THORACO-ABDOMINAL ANEURYSM), (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (STENT GRAFT WAS FENESTRATED, AGGRESSIVE BALLOONING INSIDE THE CROWN OF THE GRAFT).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM THORACO-ABDOMINAL AORTIC ANEURYSM WHICH EXTENDED FROM THE MID-DESCENDING AORTA TO JUST ABOVE THE SMA. THE PROXIMAL AORTIC NECK WAS 31 MM IN DIAMETER AND ENLARGED TO ABOUT 38 MM IN DIAMETER. THE AORTA WAS TORTUOUS. THE PT WAS NOT A CANDIDATE FOR OPEN REPAIR AND HAD A PREVIOUS ABDOMINAL EVAR REPAIR. IT WAS REPORTED THAT TALENT STENT GRAFT WAS PLACED IN THE MID-DESCENDING AORTA AFTER THE PHYSICIAN HAD MADE GRAFT FENESTRATIONS FOR THE CELIAC ARTERY AND OTHER VESSELS. THE STENT GRAFT WAS BALLOONED WITH A RELIANT BALLOON, WHICH WAS PARTIALLY INSIDE THE CROWN OF THE GRAFT. THE PHYSICIAN WAS BALLOONING AGGRESSIVELY AND OVER-INFLATED THE BALLOON. AS A RESULT THE AORTA RUPTURED (SEE MFR # 2953200-2010-02591 AND MFR# 2953200-2010-02592). A 46 MM TALENT THORACIC STENT GRAFT WAS PLACED TO SUCCESSFULLY COVER THE RUPTURE. THE PT DID NOT FEEL WELL AND IS PARAPLEGIC. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00565588

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention