BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2210595 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01413
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: ENDOLEAK. DISEASE PROGRESSION; PT REFUSED TREATMENT.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 5.5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT THE PT HAD BEEN RETURNING FOR REGULAR FOLLOW-UPS FOR THE FIRST 2 OR 3 YEARS AND WAS NOTIFIED THAT AN INTERVENTION WAS NEEDED FOR AN UNK REASON; HOWEVER, THE PT REFUSED TREATMENT AND DID NOT RETURN FOR FOLLOW-UPS SINCE THEN. APPROXIMATELY 1 MONTH AGO, THE PT PRESENTED WITH AN 8 CM DISTAL MIGRATION OF THE 28 MM DIAMETER BIFURCATED STENT GRAFT, RESULTING IN PROXIMAL TYPE I ENDO LEAK (MFR REPORT # 2953200-2011-01412); THE BIFURCATED STENT GRAFT HAD MIGRATED DOWN TO THE AORTIC BIFURCATION. AT THE TIME OF MIGRATION, THE AORTIC NECK WAS 16 MM LONG AND 33 - 34 MM DIAMETER. THE MIGRATION WAS ATTRIBUTED TO DILATATION OF THE AORTIC NECK AND DISEASE PROGRESSION. ALTHOUGH THE IPSILATERAL SIDE HAD A GOOD DISTAL SEAL AND EXTENDED TO THE LEVEL OF THE HYPOGASTRIC ARTERY, THERE WAS A DISTAL TYPE I ENDOLEAK ON THE CONTRALATERAL SIDE (MFR REPORT# 2953200-2011-01413). THE PHYSICIAN ELECTED TO INTERVENE FOR THE MIGRATION BY SUCCESSFULLY IMPLANTING 34 X 14 X 155 TALENT BIFURCATED STENT GRAFT AND A TALENT CUFF TO REBUILD UP INTO THE AORTIC NECK. FOR THE CONTRALATERAL SIDE DISTAL ENDOLEAK, THE PHYSICIAN ELECTED TO IMPLANT A 20 X 20 X 79 TALENT LIMB, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 953409

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention