BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3140328 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01043
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND ANEURYSMAL ILIAC LIMB). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND ANEURYSMAL ILIAC LIMB).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY THE ANEURYSM IS 6.1 CM IN DIAMETER. THE PATIENT WAS CURRENT WITH FOLLOW UP APPOINTMENTS. THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. CURRENTLY THERE IS VESSEL DISEASE PROGRESSION WITH AORTIC NECK DILATATION AND ILIAC LIMB DILATATION. THE AORTIC NECK IS 29 CM IN DIAMETER. THERE IS A TYPE II ENDOLEAK, LUMBAR ARTERY THAT WAS EMBOLIZED BUT WAS NOT COMPLETELY OCCLUDED. THE CT REVEALED THAT THE STENT GRAFT HAS MIGRATED 5 MM DISTALLY WITH A SMALL TYPE I ENDOLEAK PRESENT EXACT DATEOF MIGRATION IS UNKNOWN AND THE RIGHT COMMON ILIAC ARTERY IS ANEURYSMAL (2.6 CM IN DIAMETER), THE ILIAC EXTENSION STENT GRAFT (PLI-20) IS FLOATING IN THE ANEURYSMAL AREA WITH A TYPE I ENDOLEAK. THE PATIENT WAS NOT SYMPTOMATIC. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT AORTIC CUFF TO RESOLVE THE MIGRATION ASD TYPE I ENDOLEAK AND AN ENDURANT ILIAC LIMB TO TREAT THE DISTAL TYPE I ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241751 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention