BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3900544 · Received June 27, 2014

    Report

    Report Number
    2953200-2014-01306
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSIONS: OFF-LABEL USE (HIGHLY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 7 YEARS POST-INDEX PROCEDURE, AN ANEURX 242440 CUFF WAS IMPLANTED TO RESOLVE A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT FOLLOW-UP IMAGING DONE APPROXIMATELY SIX YEARS LATER REVEALED A STENT GRAFT MIGRATION WITH A PROXIMAL TYPE I ENDOLEAK. THE BIFURCATED STENT GRAFT WAS ALSO FOUND TO BE KINKED. A REVIEW OF THE RETURNED FILMS 13 YEARS POST-INDEX PROCEDURE SHOWS A KINK IN THE BIFURCATED STENT GRAFT, AS WELL AS A MIGRATION OF THE ANEURX CUFF. THERE IS A PROXIMAL TYPE I ENDOLEAK. THE PROXIMAL NECK IS ANGULATED AND SHORT. BOTH LIMBS ARE STILL PATENT. THE CAUSE OF THE MIGRATION AND KINK IS LIKELY DUE TO CONTINUED DISEASE PROGRESSION; NECK DILATATION AND ANGULATED NECK. A SECONDARY INTERVENTION WAS SUBSEQUENTLY PERFORMED. THREE ENDURANT CUFFS WERE IMPLANTED, BUT THE ENDOLEAK DID NOT RESOLVE. THE PATIENT HAS DECLINED FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377116 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04653524

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR