BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2832808 · Received November 14, 2012

    Report

    Report Number
    2953200-2012-02189
    Event Type
    Death
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, CVA); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HYPERCOAGULABLE STATE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HYPERCOAGULABLE STATE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE STRAIGHT FORWARD. IT WAS REPORTED THAT ONE WEEK POST DISCHARGE THE PATIENT PRESENTED WITH CHEST PAIN, THE PATIENT HAD A CVA. THE CT REVEALED THAT THE PATIENT'S CAROTID ARTERY WAS OCCLUDED AND THE LEFT ILIAC ARTERY WAS ALSO OCCLUDED DUE TO THE PATIENT'S HYPERCOAGULABLE STATE. THE PHYSICIAN PERFORMED A CAROTID ENDARTERECTOMY BUT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01122479

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death