BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3020043 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00526
    Event Type
    Death
    Date Received
    March 25, 2013
    Date of Event
    February 5, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON CONFIRMED THE CAUSE OF DEATH TO BE ISCHAEMIC BOWEL, WHICH PRESUMABLY WAS A COMPLICATION OF THE AAA REPAIR, BUT THE SURGEON AND INTERVENTIONAL RADIOLOGIST BOTH BELIEVE THE DEATH WAS NOT DUE TO A COMPLICATION OF THE DEVICE. THE SURGEON ALSO COMMENTED THAT THE CASE WAS DIFFICULT DUE TO A DIFFICULT NECK, BUT THE PATIENT WAS NOT FIT FOR OPEN REPAIR. THE PATIENT ALSO HAD A HISTORY OF COLITIS SAID TO BE NON-SPECIFIC ABOUT 18 MONTHS PRIOR TO THE EVAR, BUT WITH HINDSIGHT THE SURGEON SUSPECTS THIS MAY HAVE BEEN AN ISCHAEMIC EPISODE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AP PROXIMATELY SIX WEEKS AGO. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TAPERED TIP OF THE DELIVERY SYSTEM BECAME STUCK ON THE PROXIMAL END OF THE BIFURCATED STENT GRAFT. THIS MAY HAVE CAUSED THE STENT GRAFT TO MOVE SLIGHTLY AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. AN AORTIC CUFF WAS IMPLANTED AND RESOLVED THE ENDOLEAK; HOWEVER, BLOOD FLOW WAS REDUCED TO THE CONTRALATERAL LIMB. THE FINAL ANGIO SHOWED COMPLETE OCCLUSION OF THE CONTRALATERAL LIMB WITH NO OBVIOUS CAUSE. THE PHYSICIAN ATTEMPTED AN EMBOLECTOMY BUT THIS WAS NOT SUCCESSFUL. A FEMORAL-FEMORAL BYPASS WAS DONE. THE PATIENT EXPIRED FOUR DAYS POST IMPLANT. THE CAUSE OF DEATH WAS REPORTED TO BE INFECTION AND NECROSIS OF THE BOWEL DUE TO ISCHEMIA FOLLOWING COLITIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121876 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01722041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death