BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 2352071 · Received November 29, 2011

    Report

    Report Number
    2953200-2011-02036
    Event Type
    Death
    Date Received
    November 29, 2011
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (FILM EVALUATION).

    Additional Manufacturer Narrative · 1

    (B)(4) (FILM).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION AND AORTIC NECK DILATATION). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    FILM EVALUATION: THE ANEURX IS APPROX 5-6CM BELOW THE RENALS; THE STENT GRAFT IS RELATIVELY STRAIGHT WITHOUT ANY KINKS, AND IS PATENT. AORTIC CUFFS HAVE BEEN IMPLANTED BETWEEN THE ANEURX AND UP TO THE RENALS. THE LEFT SIDE OF THE MOST PROXIMAL CUFF (ENDURANT) HAS INFOLDED APPROX 15MM INWARDS. THERE IS A PROXIMAL TYPE I ENDOLEAK (OR TYPE III) VISIBLE; LIKELY CAUSED BY THE INFOLDING. EXACT CAUSE OF THE INFOLDING IS UNKNOWN; MAY BE DUE TO COMPONENT OVERSIZING FROM PLACEMENT OF A 36MM CUFF WITHIN THE 28MM ANEURX AORTIC CUFFS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL AND EXPIRED ON THE TABLE BEFORE TREATMENT. FILMS FROM APPROXIMATELY SEVEN MONTHS AGO WERE REVIEWED. THE STENT GRAFT IS APPROXIMATELY 5-6 CM BELOW THE RENALS; THE STENT GRAFT IS RELATIVELY STRAIGHT WITHOUT ANY KINKS AND IS PATENT. AORTIC CUFFS HAVE BEEN IMPLANTED BETWEEN THE ANEURX AND UP TO THE RENALS. THE LEFT SIDE OF THE MOST PROXIMAL CUFF (ENDURANT) HAS INFOLDED APPROX 15MM INWARDS. THERE IS A PROXIMAL TYPE I ENDOLEAK (OR TYPE III) VISIBLE; LIKELY CAUSED BY THE INFOLDING. EXACT CAUSE OF THE INFOLDING IS UNKNOWN; MAY BE DUE TO COMPONENT OVERSIZING FROM PLACEMENT OF A 36MM CUFF WITHIN THE 28MM ANEURX AORTIC CUFFS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED FOR A SECONDARY INTERVENTION. THERE WERE THREE ANEURX CUFFS TO BUILD UP THE GRAFT AND THEN AN ENDURANT CUFF WAS PLACED UP TO THE SMA. ON THE FINAL ANGIOGRAM THERE WAS STILL AN ENDOLEAK PRESENT. THE STENT GRAFTS WERE THEN RELINED WITH AN ENDURANT CUFF. AT THE END OF THE PROCEDURE THERE WAS STILL A SLIGHT UNKNOWN ENDOLEAK, IT WAS EITHER A TYPE 1 ENDOLEAK OR A TYPE III ENDOLEAK. THE PLAN IS FOR THE PHYSICIAN TO WATCH THE PATIENT AND GET A FOLLOW UP CT SCAN IN A MONTH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00902055

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death| R