BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3401100 · Received October 10, 2013

    Report

    Report Number
    2953200-2013-01972
    Event Type
    Injury
    Date Received
    October 10, 2013
    Report Date
    September 16, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM). EVALUATION RESULTS AND CONCLUSIONS: (STENT GRAFT MIGRATION, ENDOLEAK). (DISEASE PROGRESSION (NECK DILATATION), LACK OF PATIENT FOLLOW-UP).

    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. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW UP APPOINTMENT AND THE CT SHOWED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 3 CM RESULTING IN A PROXIMAL TYPE I. HOWEVER, THE PATIENT HAD BEEN LOST TO FOLLOW UP FOR YEARS PRIOR TO THIS. THE DATE OF EVENT WAS NOT ABLE TO BE OBTAINED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS LACK OF FOLLOW UP. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH A 3214102 AND A 1616124. AN OCCLUDER STENT GRAFT WAS IMPLANTED TO OCCLUDE THE RIGHT COMMON ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF SEVERAL STILL ANGIOGRAM IMAGES SHOW THAT THE STENT GRAFT IS APPROXIMATELY 4CM BELOW THE RENAL ARTERIES WITH A PROXIMAL TYPE I ENDOLEAK. THE NECK DIAMETER AT THE RENAL ARTERIES IS APPROXIMATELY 30MM. AN ENDURANT AUI IS SEEN POSITIONED JUST BELOW THE RENAL ARTERIES; RE-DIRECTING THE BLOOD FLOW DOWN THE LEFT SIDE. NO ENDOLEAK WAS SEEN POST-AUI IMPLANT. IT IS POSSIBLE THAT DISEASE PROGRESSION (NECK DILATATION), AS WELL AS LACK OF PATIENT FOLLOW-UP, MAY HAVE CONTRIBUTED TO THE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515224 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M03K552138

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention