BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2981644 · Received February 27, 2013

    Report

    Report Number
    2953200-2013-00349
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    October 12, 2011
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH, ENDOLEAK. PSEUDO ANEURYSM CAUSED BY PROXIMAL ANASTAMOSIS. TREATING A PSEUDO ANEURYSM PROXIMAL ANASTOMOSIS BIFEMORAL AORTA PROSTHESIS USING A TUBE GRAFT. CONCLUSION: PSEUDO ANEURYSM CAUSED BY PROXIMAL ANASTAMOSIS. TREATING A PSEUDO ANEURYSM PROXIMAL ANASTOMOSIS BIFEMORAL AORTA PROSTHESIS USING A TUBE GRAFT.

    Description of Event or Problem · 1

    AN ENDURANT AORTIC TUBE STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PSEUDO ANEURYSM PROXIMAL TO A BIFEMORAL AORTA PROSTHESIS APPROXIMATELY THREE YEARS AGO. A 4.1 CM IN DIAMETER SACCULAR ABDOMINAL AORTIC ANEURYSM WAS REPORTED WITH AN INFRA-RENAL NECK ANGLE OF 34 DEGREES. THE PROXIMAL AORTA WAS 45 MM IN DIAMETER AND THE DISTAL AORTA WAS 18 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 9 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A WOUND INFECTION FOUR MONTHS POST IMPLANT. THE PATIENT RECEIVED DRAINAGE FOR THE ABSCESS RELATED TO AN AORTA-BIFEMORAL PROSTHESIS WHICH WAS PLACED BEFORE THE ENDURANT STENT GRAFT. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED APPROXIMATELY 14 MONTHS LATER. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED; HOWEVER, THE GENERAL PHYSICIAN STATED THE PATIENT DIED PROBABLY DUE TO "LEAK." NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83373 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00430268

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death