BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2990396 · Received March 5, 2013

    Report

    Report Number
    2953200-2013-00406
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TORTUOUS AORTA). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TORTUOUS AORTA).

    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 APPROXIMATELY ONE MONTH AGO. THERE WAS SEVERE AORTIC TORTUOSITY. IT WAS REPORTED THAT THE PATIENT WAS A SYMPTOMATIC EMERGENT CASE, PRESENTING WITH ABDOMINAL AND GROIN PAIN. POST STENT GRAFT IMPLANT IT WAS NOTED THAT THERE WAS A SEPARATION TYPE III ENDOLEAK. A CUFF WAS IMPLANTED IN AN ATTEMPT TO RESOLVE THE ENDOLEAK, WHICH WAS UNSUCCESSFUL DUE TO THE AORTIC TORTUOSITY IN THE AREA WHERE THE ENDOLEAK ORIGINATED. THE ENDOLEAK DID NOT RESOLVE AND THE CASE WAS ABORTED. THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE AND WAS DISCHARGED. REVIEW OF RETURNED VIDEO OF THE ANGIO AT IMPLANT (PRIOR TO CUFF IMPLANT) SHOWS AN ENDOLEAK NEAR THE BIFURCATED STENT GRAFT FLOW DIVIDER APPROXIMATELY 3CM BELOW THE STENT GRAFT PROXIMAL GRAFT MARGIN. A STILL ANGIO IMAGE POST-CUFF IMPLANT SHOWS THE SAME ENDOLEAK NEAR THE BIFURCATE FLOW DIVIDER. FROM THESE IMAGES CANNOT CONCLUDE IF THIS IS A TYPE III FABRIC OR TYPE IV ENDOLEAK, OR POSSIBLY A PROXIMAL TYPE I ENDOLEAK. THERE APPEARS TO BE PROPER OVERLAP BETWEEN THE CONTRALATERAL LIMB AND GATE, SO UNLIKELY A TYPE III SEPARATION ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94164 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03039867

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention