BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2050863 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00748
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 5, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE SEVERELY CALCIFIED AND TORTUOUS. PT HAS A HISTORY OF SEVERE CARDIAC DISEASE. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE PT WITHOUT ISSUE. IT WAS REPORTED THAT APPROX 5 HOURS POST IMPLANT THE PT HAD A MYOCARDIAL INFARCTION. THE PT WAS TRANSFERRED TO ANOTHER FACILITY AND A CABG WAS PERFORMED. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE STENT GRAFT SYSTEM (SEE MFR # 2953200-2011-00749). NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00796596

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR