BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 2251420 · Received September 13, 2011

    Report

    Report Number
    2953200-2011-01571
    Event Type
    Death
    Date Received
    September 13, 2011
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (FILM).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (GRAFT MIGRATION, ENDOLEAK), (DISEASE PROGRESSION AND AORTIC NECK DILATATION). CONCLUSION: (DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    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.

    Description of Event or Problem · 1

    THERE HAS BEEN NO FURTHER INFORMATION PROVIDED FOR THIS CASE.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 115 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. CURRENTLY THE ANEURYSM IS 6.6 CM IN DIAMETER. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE AORTIC NECK WAS 30 MM IN DIAMETER AND 10 MM BELOW THE AORTIC NECK DIAMETER WAS 36 MM IN DIAMETER. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 3 CM WITH A TYPE I ENDOLEAK. THE PT HAS A NEW JUXTARENAL ANEURYSM. THERE IS NOT AN ENDOVASCULAR OPTION NOW, SO HIS OPTIONS ARE LIMITED. THE PT HAS EXPERIENCED RENAL FAILURE, (NOT RELATED TO THE STENT GRAFT BUT RELATED TO DISEASED RENAL ARTERIES) THEREFORE; THE PHYSICIAN IS CONSIDERING IMPLANTING AN AORTIC CUFF OVER THE RENAL ARTERY TO THE SMA WHICH WOULD EXCLUDE THE TYPE 1 ENDOLEAK. THE PT IS GOING ON DIALYSIS AND HAS DEVELOPED AN (B)(6); THE INTERVENTION IS CURRENTLY ON HOLD. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR NA M01J750976

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| R