BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5446651 · Received February 19, 2016

    Report

    Report Number
    3004753364-2016-00007
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    December 28, 2015
    Report Date
    February 19, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    05055715607032
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLUG IN LEG INFORMATION: MODEL NO. SG-HBL-90-20, LOT NO. CL62469-1, MANUFACTURE DATE. 13 MAY 2015, EXPIRY DATE. 12 MAY 2015. MODEL NO. SG-HBL-56-20, LOT NO. CL62021-1, MANUFACTURE DATE. 21 APR 2015, EXPIRY DATE. 20 APR 2017. A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THESE DEVICES 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 DEVICES HAVE NOT MET THE FINAL RELEASE CRITERIA.

    Description of Event or Problem · 1

    EVAR PERFORMED ON (B)(6) 2015. FOLLOW UP CT ON (B)(6) 2015 REVEALED OCCLUSION OF RIGHT AND LEFT INTERNAL ILIAC ARTERIES, HOWEVER NO ACTION WAS TAKEN AT THIS TIME. ON (B)(6) 2016, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF CLAUDICATION IN THEIR LEFT LEG. ABI WAS MEASURED AT 0.56. RE-INTERVENTION WAS PERFORMED ON (B)(6) 2016 TO IMPLANT A STENT IN THE LEFT INTERNAL ILIAC ARTERY TO RESTORE FLOW. AT THE END OF THE PROCEDURE, THE PHYSICIAN COULD CONFIRM THAT THERE WAS NO PRESSURE DIFFERENCE BETWEEN THE BRACHIAL PART AND THE LEG PART DISPLAYED ON THE MONITOR AFTER THE PLACEMENT OF THE STENT. THE PHYSICIAN BELIEVED THAT THE BLOOD FLOW SHOULD BE IMPROVED AND THE CLAUDICATION OF THE LEFT LEG WILL DISAPPEAR. THE RIGHT INTERNAL ILIAC WAS NOT ADDRESSED AS THE PATIENT WAS EXPERIENCING SYMPTOMS IN THE LEFT LEG ONLY, THEREFORE THE RIGHT INTERNAL ILIAC REMAINS OCCLUDED. THE PATIENT WILL BE FOLLOWED UP AT A LATER DATE. THE PHYSICIAN STATES THAT IT WAS VERY HARD TO DETERMINE THE LANDING POSITION OF THE DISTAL FISHMOUTH. THE PATIENT DID NOT HAVE ANY HISTORY OF PAD PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104141 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-24-96-80-12 CP61429-1 05055715607032

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention| S