BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2951089 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00217
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 13, 2010
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT KINK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TORTUOUS ILIAC ARTERIES). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 5.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 25 MONTHS AGO. THE AORTIC NECK WAS 23 MM IN DIAMETER PROXIMALLY, 22 MM DISTALLY AND 18 MM IN LENGTH. THE ILIAC ARTERIES WERE 11 MM IN DIAMETER BILATERALLY AND THE FEMORAL ARTERIES WERE 8 MM IN DIAMETER. BOTH ILIAC ARTERIES WERE SEVERELY TORTUOUS WITH 20% STENOSIS RESULTING IN ACCESS DIFFICULTY AT THE TIME OF IMPLANT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THERE WERE ACCESS DIFFICULTIES DUE TO KINKING WITHIN THE ILIAC ARTERY. A ROUTINE FOLLOW-UP X-RAY APPROXIMATELY ONE YEAR AGO SHOWED KINKING IN THE MAIN BODY OF THE STENT GRAFT AND INCOMPLETE OVERLAP OF THE ILIAC LIMB EXTENSIONS ON THE LEFT SIDE. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF ENDOLEAK. NO SECONDARY INTERVENTION WAS PERFORMED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53985 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00418725

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR