BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4360197 · Received December 17, 2014

    Report

    Report Number
    3004753364-2014-00024
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 18, 2014
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI#: (B)(4)). THE IFU WAS REVIEWED AND IT STATES: "EACH STENT GRAFT MUST BE ORDERED IN A SIZE APPROPRIATE TO FIT THE PATIENT'S ANATOMY. PHYSICIANS SHOULD USE ADEQUATE DIAGNOSTIC TECHNIQUES, INCLUDING CT IMAGING, TO EVALUATE FULLY THE INDIVIDUAL NEEDS OF THE PATIENT". NO FURTHER UPDATES REQUIRED. THE RISK MGMT FILE WAS REVIEWED AND DISTAL LIMB OCCLUSION IS LISTED IN THE HAZARD ANALYSIS. NO FURTHER UPDATE IS REQUIRED. THERE IS NO INFO TO SUGGEST THE DEVICE HAS NOT WORKED AS INTENDED.

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2014. DURING DEPLOYMENT OF THE MAIN BODY, THE PLANNED IPSILATERAL LEG DID NOT COVER ALL THE ANEURYSM EXPECTED LENGTH AND A DISTAL EXTENDER WAS NEEDED. ACCORDING TO THE COMPLAINANT, IT WAS HARD TO VISUALISE THE BIFURCATION OF THE RIGHT INTERNAL ILIAC AND THE DISTAL EXTENDER WAS PLACED AT THE RIGHT EXTERNAL ILIAC ARTERY. THE INTERNAL ILIAC ARTERY PATENCY WAS CONFIRMED AND THE PATIENT IS PROGRESSING WELL. IMPLANTED DEVICES: 1). SG-HBB-27-81; LOT: BW49623-1; EXP. DATE: 04/01/2016; MFR DATE: APR 2014. 2). SG-HBL-90-18; LOT: BZ49455-1; EXP. DATE: 04/01/2016, MFR DATE: APR 2014. 3) SG-HDE-16-51; LOT: CA49487-1; EXP. DATE: 05/06/2016; MFR DATE: MAY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829349 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-27-81 BW49623-1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability