BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3971735 · Received July 31, 2014

    Report

    Report Number
    2953200-2014-01489
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODE, CONCLUSION: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED 7.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BACK PAIN ONE DAY PRIOR TO PRESENTING TO THE ER. THE FOLLOWING DAY THE PATIENT PRESENTED EMERGENTLY TO THE ER. AN ENDURANT AUI WAS IMPLANTED; HOWEVER THERE APPEARED TO BE AN UNKNOWN ENDOLEAK POST IMPLANT. A SECOND LIMB WAS IMPLANTED AND THEN THERE APPEARED TO BE A TYPE II ENDOLEAK FROM A LARGE LUMBAR ARTERY. THE PHYSICIAN WAS NOT SURE IF THERE WAS A TYPE II AND A TYPE IV ENDOLEAK. A THIRD DEVICE WAS IMPLANTED AND THE ENDOLEAK RESOLVED. THE PATIENT EXPIRED HOURS AFTER THE PROCEDURE AND THEY BELIEVE THE PATIENT RUPTURED AT 7PM THE NIGHT BEFORE. CAUSE OF DEATH IS UNKNOWN, AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447633 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04035912

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death| R