BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 4241700 · Received November 10, 2014

    Report

    Report Number
    2953200-2014-02374
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THE ANEURX AORTIC CUFF HAS MIGRATED DISTALLY WITH A TYPE I ENDOLEAK. THE PHYSICIAN STATED THE CAUSE OF THE MIGRATION AND DISTAL TYPE I ENDOLEAK WAS PATIENT ANATOMY RELATED, DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 32X14X102 AUI DEVICE WITH DOUBLE SNORKEL OF RENALS LANDING THE AUI DEVICE DISTAL TO SMA, PERFORMED FEM- FEM BYPASS AND IMPLANTED AN AMPLATZER PLUG IN THE LEFT ILIAC LIMB. THE MIGRATION AND TYPE I ENDOLEAK WERE RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723162 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention