BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2170030 · Received July 15, 2011

    Report

    Report Number
    2953200-2011-01284
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    April 18, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS/CONCLUSIONS: (NO INFO ON CAUSE OF DEATH).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 12 YEARS AGO AS PART OF THE ANEURX CLINICAL TRIAL (REF. MFR #2953200-2011-00885 AND 2953200-2011-01282). ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT THE PT PRESENTED AT A ROUTINE FOLLOW UP AND THE CT SCAN DEMONSTRATED THAT THE STENT GRAFT MIGRATED 7 CM DISTALLY INTO THE ANEURYSM SAC WITH A PROXIMAL TYPE 1 ENDOLEAK PRESENT. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION AND DILATATION OF THE AORTIC NECK. THE AORTIC NECK WAS 30 MM IN DIAMETER AT THE LEVEL OF THE RENAL ARTERIES AND IT WAS MODERATELY ANGULATED. THE PT WAS TREATED WITH TWO ENDURANT AORTIC CUFFS (REF. MFR. # 2953200-2011-01283; 2953200-2011-01284) AND THE MIGRATION AND ENDOLEAK WERE RESOLVED. IT WAS REPORTED THAT THE PT EXPIRED THREE MONTHS AGO. NO FURTHER INFO IS AVAILABLE CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00828701

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death