BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1870696 · Received October 8, 2010

    Report

    Report Number
    2953200-2010-01923
    Event Type
    Death
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH, ARTERIAL TRAUMA/DISSECTION/PERFORATION). (AT 11 CM RUPTURED ABDOMINAL AORTIC ANEURYSM). (CONVERTER USED AS THE MAIN DEVICE, TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM). CONCLUSIONS: (AT 11 CM RUPTURED ABDOMINAL AORTIC ANEURYSM). (CONVERTER USED AS THE MAIN DEVICE, TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN 11CM RUPTURED ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS SEVERELY TORTUOUS WITH SEVERE CALCIFICATION, THE RIGHT ILIAC ARTERY HAD SEVERE CALCIFICATION AND THE LEFT ILIAC ARTERY WAS SEVERELY DILATED AND BOTH ILIAC ARTERIES WERE SHORT IN LENGTH, 3CM. THE PHYSICIAN INSERTED A RELIANT BALLOON, SUCCESSFULLY OCCLUDING THE BLOOD FLOW SO THE DEVICES COULD BE IMPLANTED. THE PHYSICIAN IMPLANTED A TALENT CONVERTER, HOWEVER, THE STENT GRAFT WAS PLACED ABOUT 8MM LOWER THAN INTENDED RESULTING IN A PROXIMAL TYPE I ENDOLEAK, (MFR # 2953200-2010-01921). THE PHYSICIAN IMPLANTED THE OCCLUDER DEVICE; HOWEVER. THE OCCLUDER DID NOT COMPLETELY OCCLUDE THE VESSEL, THERE WAS A TYPE I ENDOLEAK, WHICH WAS NOT TREATED, (MFR # 2953200-2010-01922). THE PHYSICIAN PLACED A TALENT AORTIC CUFF PROXIMALLY TO THE CONVERTER STENT GRAFT RESOLVING THE ENDOLEAK; HOWEVER, THE RENAL ARTERIES WERE OCCLUDED, WHICH WAS NOT TREATED. THE PHYSICIAN IMPLANTED A TALENT ILIAC LIMB DISTALLY; HOWEVER, THERE WAS NO BLOOD FLOW, (MFR# 2953200-2010-01924). THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS. IT WAS REPORTED THAT THE PT EXPIRED WHILE THE PHYSICIAN WAS CLOSING THE PT AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE PT EXPIRED DUE TO THE LARGE AMOUNT OF BLOOD LOSS FROM THE PRE-EXISTING RUPTURED ANEURYSM. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00276091

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death