BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2116642 · Received June 2, 2011

    Report

    Report Number
    2953200-2011-01090
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ENDOLEAK, MIGRATION, DEATH, RUPTURE). CONCLUSIONS: (LOST TO F/U).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM EIGHT YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT AT SOME POINT, AT A F/U, IT WAS NOTED THAT THE ANEURX STENT GRAFT HAD MIGRATED, RESULTING A TYPE I ENDOLEAK. AN ANEURX CUFF (REF MFR# 2953200-2011-01091) WAS PLACED PROXIMALLY TO INTERVENE. THE PT WAS THEN LOST TO F/U. TWO MONTHS AGO, THE PT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THERE WAS A TYPE III SEPARATION ENDOLEAK BETWEEN THE ANEURX CUFF AND BIFURCATED STENT GRAFT AND THE ANEURX STENT GRAFTS ALSO SEEMED TO HAVE BROKEN APART. A LEFT BRACHIAL APPROACH WAS ATTEMPTED, AND A GUIDEWIRE WAS BROUGHT IN VIA THE LEFT FEMORAL. ANOTHER MFR'S WAS ATTEMPTED TO BE DEPLOYED TO INTERVENE; HOWEVER, THE DEVICE WOULD NOT GET PROPER ALIGNMENT THROUGH THE METAL OF THE ANEURX STENT GRAFTS BUT ENDED UP SPONTANEOUSLY DEPLOYING. THE PT WAS STABILIZED BUT THEN DEVELOPED VENTRICULAR TACHYCARDIA AND EXPIRED AFTER UNSUCCESSFUL CPR AND DEFIBRILLATIONS. THERE WAS NO AUTOPSY PERFORMED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| R