BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 1581972 · Received January 13, 2010

    Report

    Report Number
    2953200-2010-00045
    Event Type
    Death
    Date Received
    January 13, 2010
    Date of Event
    December 6, 2005
    Report Date
    December 6, 2005
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (INTERVENTION REQUIRED) - LEAK (TYPE I ENDOLEAK; TYPE III ENDOLEAK) - EVALUATION RESULTS: DEATH, ENDOLEAK, GRAFT MIGRATION; ANTERIOR NECK ANGULATION; CAUSE OF DEATH NOT PROVIDED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 6 YEARS AGO. THE PT WAS ENROLLED IN A STUDY. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. THE PT'S MEDICAL HISTORY IS NOTABLE FOR MYOCARDIAL INFARCTION, HYPERTENSION, DIABETES, RENAL INSUFFICIENCY, AND CHRONIC OBSTRUCTION PULMONARY DISEASE. IT WAS REPORTED THAT A FOLLOW-UP CT SCAN APPROX 23 MONTHS POST-IMPLANT REVEALED A 1 CM DISTAL MIGRATION OF THE ANEURX BIFURCATED STENT GRAFT WITH A LARGE TYPE I ENDOLEAK FILLING THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO INTERVENE BY RELINING THE RIGHT ILIAC LIMB WITH AN ANEURX ILIAC LIMB AND ALSO IMPLANTING AN INVESTIGATIONAL TALENT AORTIC CUFF. THE PT'S POST-OPERATIVE COURSE WAS UNREMARKABLE, AND THE 1 MONTH FOLLOW UP CT SHOWED THAT THE GRAFTS WERE INTACT WITHOUT EVIDENCE OF KINKING OF ENDOLEAKS. APPROX 1 YEAR POST-INTERVENTION, IT WAS REPORTED THAT THE ANEURX DEVICE HAD MIGRATED DISTALLY DUE TO ANTERIOR ANGULATION WITH POOR PROXIMAL APPOSITION. IN ADDITION, THE ANEURYSM SAC HAD ENLARGED FROM 5.5 CM TO 6.1 CM, DUE TO A TYPE III ENDOLEAK, SECONDARY TO MINIMAL OVERLAP BETWEEN THE ANEURX BIFURCATED STENT GRAFT AND THE TALENT CUFF. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING 3 AORTIC CUFF STENT GRAFTS FROM ANOTHER MFR, WITH SUCCESSFUL RESULTS, FROM THE RENAL ARTERIES TO THE BIFURCATION OF THE ANEURX BIFURCATED STENT GRAFT. THE ANEURX LIMB (MFR# 2953200-2010-00046) WAS ALSO SUCCESSFULLY RELINED WITH AN ILIAC LIMB FROM ANOTHER MFR. THE INVESTIGATOR ASSESSED THAT THE MIGRATION WAS RELATED TO THE ANEURX BIFURCATED GRAFT BUT NOT RELATED TO THE PROCEDURE. APPROXIMATELY 34 MONTHS POST-INTERVENTION, THE PT EXPIRED. THE CAUSE OF DEATH HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA M03A553371

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death