BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3092043 · Received May 3, 2013

    Report

    Report Number
    2953200-2013-00815
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, VESSEL PERFORATION, DEATH. NO AORTIC NECK LENGTH, CONICAL PROXIMAL NECK, SEVERELY DISEASED AND FRAIL VESSELS. NO AORTIC NECK LENGTH. CONCLUSION: NO AORTIC NECK LENGTH, CONICAL PROXIMAL NECK, SEVERELY DISEASED AND FRAIL VESSELS. NO AORTIC NECK LENGTH.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A CONICAL 5.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM THAT NARROWED TO 2.7 CM AND EXPANDED OUT TO APPROXIMATELY 4 CM IN DIAMETER. THE PATIENT WAS NOT A CANDIDATE FOR OPEN SURGICAL REPAIR. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS NO AORTIC NECK, THE VESSEL WAS SEVERELY DISEASED AND FRAIL, THE AORTIC NECK WAS 25 MM IN DIAMETER AT THE RENAL ARTERIES AND 10 MM BELOW THE RENAL ARTERIES THE AORTIC NECK WAS 29 MM IN DIAMETER. THERE WAS MILD THROMBOSIS THROUGHOUT THE VESSELS. THE STENT GRAFTS WERE IMPLANTED HOWEVER SINCE THERE WAS NO AORTIC NECK THERE WAS A LARGE PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFT WITH A RELIANT BALLOON WITH NORMAL SALINE CONTRAST SOLUTION DURING THE MODELING OF THE STENT GRAFT THE VESSEL WAS PERFORATED WHERE THE ANEURYSM/AORTA NARROWED DOWN TO 2.7 CM IN DIAMETER, AND THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN OPENED THE PATIENT AND CLAMPED THE AORTA ABOVE THE BIFURCATED STENT GRAFT TO GAIN BLOOD PRESSURE CONTROL HOWEVER, WHEN THE CLAMP WAS PLACED THE AORTA DISINTEGRATED. THE PHYSICIAN ATTEMPTED TO CLAMP HIGHER PROXIMALLY TO THE CELIAC ARTERY, BUT THE AORTA CONTINUED TO DISINTEGRATE. THE PHYSICIAN WAS UNABLE TO CONTROL THE BLEEDING AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194786 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03997534

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Death