BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1983097 · Received February 4, 2011

    Report

    Report Number
    2953200-2011-00276
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK, MIGRATION, RUPTURE). EVAL, RESULTS/CONCLUSION: (SEVERELY ANGULATED AORTIC NECK, 90 DEGREES).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM ABDOMINAL AORTIC ANEURYSM APPROX 12 MONTHS AGO. THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 24-26 MM IN DIAMETER OVER A LENGTH OF 1 CM AND WAS SEVERELY ANGULATED AT ABOUT 90 DEGREES ANTERIOR. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ANEURX BIFURCATED STENT GRAFT KEPT SLIPPING DISTALLY, DUE TO THE AORTIC NECK ANGULATION (REF MFR # 2953200-2011-00275). TWO ANEURX 28 MM CUFFS (REF MFR # 2953200-2011-00277) AND A TALENT 28 MM AORTIC CUFF (REF MFR # 2953200-2011-00278) WERE PLACED PROXIMALLY DUE TO THE CONTINUAL SLIPPAGE OF THE BIFURCATED STENT GRAFT. THE PROCEDURE WAS COMPLETED. THE PT PRESENTED ONE YEAR POST IMPLANT WITH BACK PAIN, AND IT WAS NOTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK, AS THE BIFURCATED STENT GRAFT AND ALL 3 PROXIMAL AORTIC CUFFS HAD MIGRATED TOGETHER 3 CM TO 4 CM DISTALLY DUE TO THE SEVERE NECK ANGULATION. THERE WAS NO CHANGE IN ANEURYSM SIZE OR NECK ANGULATION SINCE THE TIME OF IMPLANT. THE PT WAS SCHEDULED FOR AN INTERVENTION, HOWEVER, BEFORE THE PLANNED INTERVENTION THE PT'S ANEURYSM RUPTURED. THE PT WAS TAKEN TO THE OPERATING ROOM AND A CHIMNEY PROCEDURE WAS PERFORMED ON THE LEFT RENAL TO ALLOW PLACEMENT OF AN ENDURANT BIFURCATED GRAFT (REF MFR # 2953200-2011-00279), WHICH WAS INTENDED TO CREATE AN AUI CONFIGURATION BY A JAILING THE EXISTING ANEURX CONTRALATERAL LIMB. THE PHYSICIAN THOUGHT AN AUI WOULD HANDLE THE DIFFICULT NECK ANATOMY THE BEST. AN AMPLATZER PLUS WAS PLACED INTO THE LEFT SIDE/CONTRALATERAL ANEURX LIMB, FOLLOWED BY A FEM-FEM BYPASS. THE ANGIOGRAM SHOWED A PROXIMAL TYPE I ENDOLEAK, WHICH WAS SUCCESSFULLY REPAIRED BY COILING AND GLUE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00406885

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention