BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 4153213 · Received October 8, 2014

    Report

    Report Number
    2953200-2014-02019
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT ARE UNKNOWN. A 28X28X40 WAS USED TO EXTEND THE 18X24X135 IN THE RIGHT ILIAC AT THE ORIGINAL IMPLANT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY SEVEN YEARS POST INDEX PROCEDURE. THE LIMB FROM THE RIGHT ILIAC WAS DRAWN UP INTO THE AORTA AFTER THE RIGHT ILIAC DILATED AND THERE WAS A TYPE 1B ENDOLEAK FROM THAT AREA. THE 18X24X85 COMING OUT OF THE BIFURCATE WAS IMPLANTED ON THE LEFT SIDE AND IT LOOKED FINE. THE PROXIMAL AORTA AT THE RENAL ARTERIES WAS DILATED TO 29 MM, THERE WASN'T A LEAK BUT THE PHYSICIAN WANTED TO GO AHEAD AND PLACE THE CUFF TO PREVENT A FUTURE LEAK. IT WAS DECIDED TO EMBOLIZE THE RIGHT HYPOGASTRIC ARTERY AND EXTEND THE RIGHT LIMB INTO THE RIGHT EXTERNAL ILIAC WITH A 16X10X156 AND PLACE A 32X32X49 IN THE PROXIMAL INFRA RENAL NECK. THE ENDOLEAK RESOLVED AFTER THE REPAIR AND THE PATIENT IS DOING FINE PER THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631227 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00025559

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention