BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1730765 · Received June 18, 2010

    Report

    Report Number
    2953200-2010-01163
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL RESULTS: DEATH, ENDOLEAK, ARTERIAL AND VENOUS OCCLUSION; SHORT AORTIC NECK; DEVICE WAS USED IN A PATIENT WITH A INADEQUATE VESSEL MORPHOLOGY.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 7 MM LONG AND 41.8 MM IN DIAMETER AT 10 MM BELOW THE RENALS. THE NECK ALSO HAD MORE THAN 50% THROMBUS AROUND THE RENALS. THE PATIENT HAD CO-MORBIDITIES, AND WAS NOT AN OPEN REPAIR CANDIDATE. THE VESSELS HAD SOME TORTUOSITY AND CALCIFICATION. THE PHYSICIAN COMMENTED THAT A TYPE 1 ENDOLEAK WOULD LIKELY OCCUR POST IMPLANT DUE TO THE PATIENT'S VESSEL MORPHOLOGY. THE TALENT BIFURCATED STENT GRAFT WAS IMPLANTED VERY PROXIMALLY DUE TO THE SHORT NECK AND LANDED INTENTIONALLY RIGHT BELOW THE SMA, SO THE RENALS WERE COVERED. A RENAL-FEMORAL BYPASS WAS THEN PERFORMED ON THE LEFT SIDE TO PERFUSE THE LEFT RENAL ARTERY; HOWEVER, THE PATIENT MAY HAVE BEEN WITHOUT RENAL FLOW FOR UP TO 45 MINUTES. A PROXIMAL TYPE 1 ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE, BUT THERE WAS NO ROOM PROXIMALLY TO PLACE A CUFF OR PALMAZ. THE ENDOLEAK WAS LEFT UNTREATED, BUT THE PATIENT WAS STABLE. THE PATIENT REPORTEDLY EXPIRED 3 DAYS POST-IMPLANT FROM CO-MORBIDITIES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00451816

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death