BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1192604 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00912
    Event Type
    Death
    Date Received
    October 8, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - DEATH, ENDOLEAK, MIGRATION. AORTIC NECK DILATATION DUE TO DISEASE PROGRESSION. CONCLUSIONS - AORTIC NECK DILATATION DUE TO DISEASE PROGRESSION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM SIZE AT THE TIME OF IMPLANT IS UNK. THERE WAS 10 PERCENT OVERSIZING, THE AORTIC NECK HAD A 10 DEGREE ANGULATION, AORTIC NECK HAD AN AP ANGULATION OF 10 DEGREES, THE AORTIC NECK WAS REVERSE FUNNEL FROM 23 MM AT THE RENAL ARTERIES AND 15 MM BELOW THE RENAL ARTERIES IS 32 MM, AND DISEASE PROGRESSION WITH AORTIC NECK DILATATION. IT WAS REPORTED 40 MONTHS POST STENT GRAFT IMPLANT, THE CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 12 MM RESULTING IN A TYPE I ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN PLACED TWO TALENT CUFFS, DUE TO THE PT'S AORTIC NECK DILATATION FROM 26 MM TO 32 MM IN DIAMETER. THE MOST PROXIMAL CUFF WAS PLACED UP TO THE LOWEST (LEFT) RENAL ARTERY. THE PHYSICIAN MODELLED THE AORTIC CUFFS WITH A RELIANT STENT GRAFT BALLOON. THE BALLOON WAS INFLATED WITH A 20 CC SYRINGE CONTAINING CONTRAST 25/SALINE75 AT AN UNK VOLUME. THE FINAL ANGIOGRAM OF THE CASE HAD GOOD RESULTS. IT IS POSSIBLE THAT THERE WAS A SLIGHT TYPE I ENDOLEAK, HOWEVER, WHEN THE HEPARIN WORE OFF, THE PHYSICIAN BELIEVES THAT THE ENDOLEAK WOULD RESOLVE. TWO DAYS LATER, THE PHYSICIAN WAS ALERTED BY THE HOSPITAL THAT THE PT WAS UNSTABLE. THE PT WAS TRANSPORTED FROM ONE HOSPITAL TO ANOTHER HOSPITAL. THE PT WAS TAKEN IN TO SURGERY. WHEN THE PHYSICIAN OPENED THE PT, THERE WAS A PERFORATION IN THE AORTA AT THE TOP LEVEL OF THE STENT GRAFT AND LEVEL WITH THE RENAL ARTERIES. THE PHYSICIAN CONVERTED THE PT WITH A CONVENTIONAL STENT GRAFT, HOWEVER DUE TO PT CONDITION AND BLOOD LOSS, THE PT EXPIRED. THE PHYSICIAN BELIEVES THAT HE MAY HAVE AGGRESSIVELY BALLOONED THE TALENT CUFFS WHICH MAY HAVE DISSECTED THE VESSEL AND OVER THE NEXT TWO DAYS, A PERFORATION OF THE VESSEL OCCURRED. REFERENCE MDR: 2953200-2008-00913, 00914, 00915.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 531141

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death