BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2993535 · Received March 7, 2013

    Report

    Report Number
    2953200-2013-00420
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: OTHER (FILM). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION, ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (AORTIC NECK DILATATION AND ANGULATION). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (AORTIC NECK DILATATION AND ANGULATION).

    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 EIGHT YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. THE CURRENT DIAMETER OF THE AORTIC NECK IS 22MM, THE ANEURYSM DIAMETER IS 39MM AND THE LENGTH IS 44MM. IT WAS REPORTED THAT THE STENT GRAFT HAD MIGRATED 3CM WITH NECK DILATATION AND A PROXIMAL TYPE I ENDOLEAK. DESPITE THE ENDOLEAK THE ABDOMINAL AORTIC ANEURYSM REMAINS SMALL. NO INTERVENTION WAS PERFORMED AND THE PHYSICIAN WILL MONITOR THE PATIENT. REVIEW OF RETURNED FILMS POST-IMPLANT CONFIRMED THAT THE STENT GRAFT HAS MIGRATED DOWN APPROXIMATELY 3CM BELOW THE RENAL ARTERIES WITH A PROXIMAL TYPE I ENDOLEAK. THE PROXIMAL NECK DIAMETER (FLOW LUMEN) BELOW THE RENAL ARTERIES MEASURES 20MM X 25MM, AND 10MM BELOW THE RENAL ARTERIES MEASURES 25 X 37MM. THE NECK IS ANGULATED TO APPROXIMATELY 80 DEGREES; HOWEVER, THE STENT GRAFT DOES NOT APPEAR KINKED AT THE FLOW DIVIDER OR LIMBS. THE AAA MEASURES 4CM, AND THERE IS GOOD DISTAL SEALING AT THE ILIAC LIMBS. EARLIER FOLLOW-UP IMAGES WERE NOT PROVIDED. IT IS LIKELY THAT DISEASE PROGRESSION (NECK DILATATION AND ANGULATION) CONTRIBUTED TO THE STENT GRAFT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98219 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR