BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT AUI STENT GRAFT SYSTEM

    MDR report key: 2062285 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00673
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 5.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS SEVERELY ANGULATED 76 DEGREES, 17 MM IN DIAMETER AND 27 MM IN LENGTH. IN THE RIGHT ILIAC ARTERY, THERE WAS 70 PERCENT STENOSIS AND THE LEFT ILIAC ARTERY HAD MODERATE TORTUOSITY WITH 40 PERCENT STENOSIS. THE ENDURANT AUI STENT GRAFT SYSTEM WAS INSERTED IN THE PT FROM THE RIGHT SIDE AND A TALENT 14 MM OCCLUDER WAS USED ON THE LEFT SIDE. THE FINAL ANGIOGRAM REVEALED A SLIGHT LATE BLUSHING TYPE IV ENDOLEAK. THE INVESTIGATOR ASSESSMENT WAS NOT REPORTED. NO INTERVENTION WAS OR HAS BEEN PERFORMED AND THE DECISION WAS MADE TO EVALUATE MONITOR THE PT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT AUI STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00335452

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male