BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4148231 · Received October 2, 2014

    Report

    Report Number
    3004753364-2014-00017
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 3, 2014
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI#S: (B)(4). A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THESE DEVICES HAVE BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCTS WERE MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECS. THERE IS NO INFO TO SUGGEST THAT THE DEVICES HAVE NOT MET THE FINAL RELEASE CRITERIA. RISK ANALYSIS: THERE ARE A NUMBER OF REASONS FOR DISSECTION OF THE ILIAC INCLUDING BUT NOT LIMITED TO: EXCESS FORCE DURING INSERTION OF THE DEVICE, DELIVERY SYSTEM TOO LARGE, EXCESSIVELY CALCIFIED VESSELS. LOMBARD MEDICALS HAZARDS RISK ANALYSIS HAS BEEN REVIEWED AND DISSECTION OF ILIAC IS LISTED. NO FURTHER UPDATE REQUIRED. CONCLUSION: THERE IS NO EVIDENCE TO SUGGEST THE DEVICE HAS NOT WORKED AS INTENDED. LOMBARD MEDICAL WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH THE QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    THE PT UNDERWENT AN EVAR PROCEDURE ON THE (B)(6) 2014. POST-EVAR ANGIO SCAN PERFORMED RIGHT AFTER THE PROCEDURE SHOWED NO ADVERSE EVENT. ON THE FOLLOWING DAY ((B)(6) 2014) THE POST-OPERATIVE CT SCAN SHOWS SUSPECTED DISSECTED LEFT EIA. A RE-INTERVENTION WAS DONE TO PLACE A RECOVERED STENT TO THE DISSECTED AREA. SUSPECT MEDICAL DEVICES: 2. MODEL: SN-HBL-56-16, LOT # BZ49074-1, EXPIRY DATE: JANUARY 7, 2016. MFG DATE: JANUARY 2014. DEVICE 3: MODEL SG-HBL-73-14, LOT # BZ49074-1, EXPIRY DATE: APRIL 24, 2016. MFG DATE APRIL 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614335 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG0HBB-24-81 BW49345-1

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization