BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 4093232 · Received September 16, 2014

    Report

    Report Number
    2953200-2014-01840
    Event Type
    Death
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRE-OP RUPTURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED AAA MEASURING APPROXIMATELY 6 CM IN DIAMETER. THE PATIENT HAS ADMITTED URGENTLY, INTUBATED WITH PRESSURES IN THE 50-60¿S AND VERY UNSTABLE. THE PATIENT¿S ABDOMEN WAS VERY LARGE AND FULL OF BLOOD. THE PATIENT HAD AN ANTERIOR RUPTURE. THE PHYSICIAN DELIVERED THE STENT GRAFTS WITHOUT ANY ISSUES. A FINAL ANGIO SHOWED NO TYPE I ENDOLEAK BUT A LATE TYPE II. THE PHYSICIAN DECIDED TO OPEN THE PATIENT¿S ABDOMEN TO RELIVE COMPARTMENT SYNDROME. THE IMA AND MULTIPLE LUMBAR ARTERIES WERE LIGATED; HOWEVER, THE PATIENT STILL HAD ACTIVE BLEEDING. THE PATIENT¿S PRESSURE CONTINUED TO DROP AFTER MANY UNITS OF BLOOD AND SUBSEQUENTLY THE PATIENT CODED. THE PHYSICIAN WAS ABLE TO RESUSCITATE THE PATIENT; HOWEVER, THE PATIENT CODED A SECOND TIME AND COULD NOT BE RESUSCITATED. THE PATIENT EXPIRED DUE TO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571041 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04120380

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death| R