BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 3940374 · Received June 17, 2014

    Report

    Report Number
    3004753364-2014-00010
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 18, 2014
    Manufacturer
    LOMBARD MEDICAL LTD
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE HAS NOT MET THE FINAL RELEASE CRITERIA. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL TO DATE.

    Description of Event or Problem · 1

    IN ROUTINE FOLLOW-UP THE SURGEON HAD TO EMERGENTLY THROMBECTOMIZE THE RIGHT LIMB OF THE EXISTING GRAFT AND ILIAC ARTERY DUE TO STENOSIS WITHIN THE GRAFT. THE GRAFT WAS BALLOONED OUT TO 8MM AND STENTED. THE PATIENT IS PROGRESSING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355151 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD SG-HBB BK44891-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention