BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4178533 · Received September 18, 2014

    Report

    Report Number
    3004753364-2014-00016
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI#S: (B)(4). ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED IN ORDER TO ALLOW A THOROUGH INVESTIGATION TO TAKE PLACE. UPON RECEIPT AND ASSESSMENT A FINAL REPORT SHALL BE FILED.

    Description of Event or Problem · 1

    A TYPE 1A ENDOLEAK WAS VERBALLY REPORTED. A RE-INTERVENTION WAS PERFORMED ON THE (B)(6) 2014 AND THE ENDOLEAK WAS SUCCESSFULLY CLOSED. THE PATIENT IS PROGRESSING WELL. MODEL: SG-HBL, LOT NUMBER: BL44701-1, EXPIRY DATE: 11 FEB 2016, MANUF DAT: FEB/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579184 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB BK50680-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R