BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3103635 · Received May 9, 2013

    Report

    Report Number
    2953200-2013-00873
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH. ANATOMY RELATED: RUPTURED ABDOMINAL AORTIC ANEURYSM. TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. CONCLUSION: ANATOMY RELATED: RUPTURED ABDOMINAL AORTIC ANEURYSM. TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.

    Description of Event or Problem · 1

    A TALENT CONVERTER STENT GRAFT SYSTEM AND AN ENDURANT STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS NOT REPORTED. THE PATIENT'S BLOOD PRESSURE WAS LOW (EXACT AMOUNT UNKNOWN) PRIOR TO THE IMPLANTATION OF THE DEVICES. THE PHYSICIAN ELECTED TO IMPLANT A TALENT CONVERTER AND AN ENDURANT ILIAC EXTENSION EMERGENTLY DUE TO THE RUPTURED ANEURYSM AND HYPOTENSION. THE STENT GRAFTS WERE IMPLANTED WITHOUT ISSUES HOWEVER THE PATIENT'S BLOOD PRESSURE DID NOT INCREASE. AN ANGIOGRAM REVEALED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK. ANOTHER MANUFACTURER'S AORTIC CUFF WAS IMPLANTED COVERING THE RENAL ARTERIES AND MODELED WITH A BALLOON; THE PATIENT'S BLOOD PRESSURE STILL DID NOT INCREASE. THE ANESTHESIOLOGIST REPORTED THAT THERE WAS NO CAROTID PULSE AND PRESSURE WAS EXTREMELY LOW. THE PHYSICIAN DECIDED TO END THE CASE AS THE PATIENT'S BLOOD PRESSURE COULD NOT BE RESTORED AND THERE WAS NO FURTHER ACTIONS THE PHYSICIAN COULD TAKE TO RESTORE THE BLOOD PRESSURE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203632 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01704077

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death