BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX XPEDIENT STENT GRAFT (FLEXIBLE HD) SYSTEM

    MDR report key: 2032680 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00710
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    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, MYOCARDIAL INFARCTION, ANEURYSM RUPTURE; (DETAILS FOR OF THE EVENT AND CAUSE OF DEATH WERE NOT REPORTED). EVAL CODES, CONCLUSION: (DETAILS FOR OF THE EVENT AND CAUSE OF DEATH WERE NOT REPORTED).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM AND ITS COMPONENTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY SIX YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT AND CURRENTLY WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED EMERGENTLY ONE MONTH AGO FOR AN UNK REASON. THE PT PRESENTED EITHER WITH A MYOCARDIAL INFARCTION OR A RUPTURED ABDOMINAL AORTIC ANEURYSM, OR A COMBINATION OF THE TWO. IT WAS REPORTED THAT THE PT'S ANEURYSM MAY HAVE BEEN RUPTURED DURING THE CHEST COMPRESSION FOR THE LIFE SAVING ATTEMPT, AFTER A MYOCARDIAL INFARCTION. THE PT EXPIRED THE SAME DAY. (REF # 2953200-2011-00708, AND 2953200-2011-00709).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX XPEDIENT STENT GRAFT (FLEXIBLE HD) SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 293200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death