BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3251916 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01454
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDTRONIC IREALAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, 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, CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (DEATH), DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM), OFF¿LABEL UNAPPROVED OR CONTRAINDICATED USE (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 ENDOVASCULAR TREATMENT OF AN EMERGENT RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED POST¿OPERATIVELY. THE ENDURANT DEVICE WAS IMPLANTED INTO THE PATIENT WHICH EXCLUDED THE ANEURYSM, HOWEVER THE TEAR IN THE AORTA WAS SO LARGE THAT THE PATIENT LUMBAR CAUSED EXSANGUINATION OF THE PATIENT. IT WAS REPORTED THAT THE PATIENT DEATH WAS NOT DEVICE RELATED AND THERE IS NO ALLEGED PRODUCT ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353178 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IREALAND V00956176

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death