BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT

    MDR report key: 3002980 · Received March 13, 2013

    Report

    Report Number
    2953200-2013-00452
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 16, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM). UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM) EVALUATION CODES, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM), OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN 11 CM DIAMETER PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. IT WAS REPORTED THAT WHEN THE PATIENT ARRIVED TO THE ER THEY WERE RECEIVING CHEST COMPRESSIONS. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT THE ENDURANT STENT GRAFTS. UPON COMPLETION THE RUPTURE WAS SEALED AND THERE WERE NO ENDOLEAKS, THE PATIENT WAS STABILIZED. UPON DECOMPRESSING THE PATIENT THE PHYSICIAN NOTED ABNORMAL CHANGES IN EKG. THE PATIENT PASSED AWAY DUE TO COMPARTMENT SYNDROME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106097 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03013600

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death