BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3081251 · Received April 26, 2013

    Report

    Report Number
    2953200-2013-00789
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: MIGRATION. DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND TYPE II ENDOLEAK. CONCLUSION: DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND TYPE II ENDOLEAK.

    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 THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 30 MM IN DIAMETER AT THE RENAL ARTERIES. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. A RECENT CT/ANGIOGRAM REVEALED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 2 CM, THERE IS NO TYPE I ENDOLEAK HOWEVER, THERE IS A TYPE II ENDOLEAK COMING FROM A LUMBAR ARTERY. THE PHYSICIAN ELECTED TO IMPLANT A 36X36X49 ENDURANT AORTIC CUFF AND THE MIGRATION WAS RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181124 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00317576

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR