BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 1982461 · Received February 3, 2011

    Report

    Report Number
    2953200-2011-00261
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (RENAL FAILURE, STENT GRAFT KINKING, DEATH), (SEVERE ILIAC TORTUOSITY BILATERALLY AND STENOSIS OF 50 PERCENT). CONCLUSION: (SEVERE ILIAC TORTUOSITY BILATERALLY AND STENOSIS OF 50 PERCENT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM FUSIFORM ABDOMINAL AORTIC ONE YR AGO. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS AN ANGLE BETWEEN PROXIMAL AORTIC NECK AND MAIN AXIS OF AAA IS 20 DEGREES, THE AORTIC NECK BELOW THE RENAL ARTERIES IS 21 MM IN DIAMETER, DISTAL DIAMETER IS 20 MM, ITS LENGTH IS 12 MM. THERE WAS SEVERE BILATERAL ILIAC TORTUOSITY. RIGHT ILIAC STENOSIS WAS 50% AND THE LEFT WAS 10%. IT WAS REPORTED THERE WAS STENT GRAFT KINKING OBSERVED AT THE RIGHT ILIAC ARTERY DURING INDEX PROCEDURE AND STENT GRAFT KINKING REPORTED AT DISCHARGE IMAGE. THE STENT GRAFT WAS PATENT. IT WAS REPORTED THAT THE PT EXPIRED, DUE TO CARDIAC DECOMPENSATION (WITH RELATED RENAL INSUFFICIENCY). THE INVESTIGATOR ASSESSED THAT THE PT'S DEATH WAS NOT RELATED TO THE DEVICE OR PROCEDURE. (MFR REPORT# 2953200-2011-00262).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00314539

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death