BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5652420 · Received May 13, 2016

    Report

    Report Number
    3004753364-2016-00014
    Event Type
    Injury
    Date Received
    May 13, 2016
    Report Date
    May 11, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    0505571560688
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER AORFIX DEVICES USED IN THE PROCEDURE: PLUG-IN LEG INFORMATION: MODEL NO. SG-HBL-56-16, LOT NO. CL62461-1, MANUFACTURE DATE. 21 MAY 2015, EXPIRY DATE. 20 MAY 2017. MODEL NO. SG-HBL-56-18, LOT NO. CL62570-1, MANUFACTURE DATE. 01 MAY 2015, EXPIRY DATE. 30 APRIL 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. A RE-INTERVENTION WAS PERFORMED. A FEM-FEM BYPASS WAS CARRIED OUT. NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    ORIGINAL EVAR PERFORMED (B)(6) 2016. A MAIN BODY (HBB-24-81-80-18) WAS INSERTED BY THE LEFT FEMORAL APPROACHING. THEN, THE MAIN BODY DEVICE WAS DEPLOYED TO BECOME SHORTER AND PLACED IN THE POSITION TO SLIGHTLY COVER THE COMMON ILIAC ARTERY. ADDITIONALLY, ANOTHER DEVICE (HBL-56-18-A13) WAS PLACED AS AN EXTENDER AND A BALLOON-CATHETER INFLATION WAS PERFORMED. THEN, HE PLACED A CONTRA-LATERAL LEG (HBL-56-16-A13) AND PERFORMED AN INFLATION OF THE BALLOON CATHETER. THE FINAL ANGIOGRAPHY REVEALED THAT AN OVERLAPPED EXTENDER PORTION OF THE IPSI-LATERAL LIMB PUSHED THE CONTRA-LATERAL LIMB TO BECOME A BIT NARROWER. HOWEVER, THE PHYSICIAN CONFIRMED THAT THE DIAMETER OF ITS INTERNAL LUMEN WAS MEASURED AS 7 MM AND NO ISSUE ABOUT THE BLOOD FLOW, WHICH LED TO A CONCLUSION NOT TO ADD A BARE STENT. THE PROCEDURE WAS FINISHED AT THIS STAGE. ON (B)(6) 2016, THE CT IMAGE REVEALED NO PROBLEM. AT THE END OF (B)(6) 2016, A THROMBOTIC OCCLUSION OF THE CONTRA-LATERAL LIMB WAS CONFIRMED AROUND THE TERMINAL AORTA. A RE-INTERVENTION WAS PERFORMED AND A FEM-FEM BYPASS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307631 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-24-81-80-18 CP60067-1 0505571560688

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention