BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2993577 · Received March 7, 2013

    Report

    Report Number
    2953200-2013-00427
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION).

    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 APPROXIMATELY SIX YEARS AGO. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. THE AORTIC NECK WAS 21MM IN DIAMETER AND 45MM LONG. THE LEFT COMMON ILIAC WAS 16/15/14MM IN DIAMETER AND THE RIGHT WAS 13/14/12MM. IT WAS REPORTED THAT PROXIMAL AND DISTAL TYPE I ENDOLEAKS WERE OBSERVED AND TREATED. THE ENDOLEAKS DID NOT SHOW UP ON ANGIO BUT WERE SEEN ON CT. THERE WAS DISEASE PROGRESSION WITH A POSSIBLE MIGRATION. THE PROXIMAL AORTIC NECK WAS 23MM IN DIAMETER AND 40MM LONG. THE INFRARENAL NECK ANGLE WAS 45 DEGREES. THE PHYSICIAN TREATED THE ENDOLEAKS WITH AN ENDURANT 282849 AORTIC CUFF WHICH WAS PLACED IN THE PROXIMAL AORTIC NECK, AN ENDURANT 161682 IN THE DISTAL RIGHT COMMON ILIAC ARTERY AND AN ENDURANT 162082 IN THE DISTAL LEFT COMMON ILIAC ARTERY. THE ENDOLEAKS WERE RESOLVED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98244 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000132

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention