BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2202067 · Received August 5, 2011

    Report

    Report Number
    2953200-2011-01398
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: (EMBOLI). RESULTS/CONCLUSIONS: (PRE-EXISTING RENAL ISSUES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNKNOWN SIZE. THE PATIENT HAS A HISTORY OF THE REMOVAL OF THE LEFT KIDNEY. PRE-OPERATIVELY, THE PATIENT'S CREATININE LEVEL WAS 4.0; THE RIGHT RENAL ARTERY WAS PATENT BUT VERY SMALL AND THE RIGHT KIDNEY WAS NECROSED. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS PLACED BELOW THE RIGHT RENAL ARTERY AND DURING THE ANGIOGRAM RUN, THE RENAL ARTERY WAS OPEN; HOWEVER, ON THE FINAL ANGIOGRAM RUN, THE RIGHT RENAL ARTERY WAS OCCLUDED. THE PHYSICIAN CONFIRMED THAT STENT GRAFT PLACEMENT WAS APPROPRIATE AND THINKS THAT A PIECE OF PLAQUE MAY HAVE MOVED TO CAUSE THE RENAL OCCLUSION. TO INTERVENE, THE PHYSICIAN ATTEMPTED TO CANNULATE THE RENAL ARTERY BUT WAS UNSUCCESSFUL. THE PATIENT HAS BEEN PLACED ON DIALYSIS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00856553

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention