BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5384759 · Received January 22, 2016

    Report

    Report Number
    3004753364-2016-00004
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 22, 2015
    Report Date
    February 19, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    05055715606493
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION IS IN PLACE AND FINAL MDR SHALL BE FILED UPON ITS CONCLUSION.

    Additional Manufacturer Narrative · 1

    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 AND THERE IS NO INFORMATION TO SUGGEST MALFUNCTION OF THE IMPLANT. THE PATIENT HAD A BLOOD COAGULATION DISORDER WHICH MAY HAVE CONTRIBUTED TO THROMBOSIS OF THE LIMB. THE PHYSICIAN HAS CONFIRMED THAT THE GRAFTS ARE PATENT FOLLOWING THE THROMBECTOMY PERFORMED AND THAT THE EVENT WAS NOT RELATED TO THE STENT GRAFTS DIRECTLY. AS OF (B)(6) 2016, THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS FAVOURABLE.

    Description of Event or Problem · 1

    ON (B)(6) AN URGENT PROCEDURE WAS PERFORMED WITH USE OF AORFIX STENT GRAFTS FOLLOWING THE IFU. AT THAT TIME, THE PROCEDURE WAS FINISHED WITHOUT PROBLEM.RIGHT LEG: GRAFT CONSTRICTED IN SIZE AND LEFT LEG OCCLUDED DUE TO THROMBOSIS STENT GRAFTS AND ALL DEVICES WERE PLACED APPROACHING FROM THE LEFT FEMORAL ARTERY FOR ABDOMINAL EVAR.ON (B)(6) A DEALER INFORMED MEDICO'S HIRATA OF THE OCCLUSIONS PROBLEM DUE TO THROMBOSIS.REGARDING THE LEFT LEG, THE OCCLUSION DUE TO THROMBOSIS WAS CONFIRMED FROM THE BIFURCATION OF THE MAIN BODY TO THE DISTAL PART OF THE EXTERNAL ILIAC ARTERY. REGARDING THE RIGHT LEG, APPROXIMATELY HALF OF THE GRAFT FROM THE CONTRA-LATERAL LEG WAS CONSTRICTED IN SIZE.BUT THE RING STENT ITSELF WAS FULLY EXPANDED.ADDITIONAL PROCEDURE: SURGICALLY, A THROMBECTOMY WAS CONDUCTED. AFTER THE CUTDOWN, ACT VALUE WAS MEASURED. WITH A UNIT OF 11,000 INTRAVENOUS INJECTION WAS CONDUCTED AND ACT VALUE SHOWED 237. ABOUT EVERY 30 MINUTES, ADDING IT WITH A UNIT OF 1500, AND FINALLY, THE ACT VALUE SHOWED 228 AFTER APPROXIMATELY ONE HOUR. THE PROCEDURE WAS FINISHED.ANATOMY: PROXIMAL NECK ANGULATION: 131 DEGREE. OUTSIDE THE IFU.PHYSICIAN'S COMMENT: IT IS DIFFICULT TO IDENTIFY A CAUSE OF THIS EVENT. IT IS ASSUMED THAT IT MIGHT BE BECAUSE OF THE PATIENT'S BLOOD COAGULATION DISORDERS.IMPLANTS USED IN THIS CASE:MODEL NUMBER LOT NUMBER EXPIRY DATE MANUFACTURE DATE UDISG-HBB-24-111-80-12 CP62409-1 04 JUN 2017 04 JUN 2015 (01)05055715606493(17)170604(10)CP62409-1SG-HBL-73-10 CL65069-1 21 JUL 2017 21 JUL 2015 (01)05055715612487(17)170721(10)CL65069-1SG-HBL-106-10 CL65864-1 18 AUG 2017 18 AUG 2017 (01)05055715612302(17)170818(10)CL65864-1

    Description of Event or Problem · 1

    ON (B)(6), AN URGENT PROCEDURE WAS PERFORMED WITH USE OF AORFIX STENT GRAFTS FOLLOWING THE IFU. AT THAT TIME, THE PROCEDURE WAS FINISHED WITHOUT PROBLEM. RIGHT LEG: GRAFT CONSTRICTED IN SIZE AND LEFT LEG OCCLUDED DUE TO THROMBOSIS STENT GRAFTS AND ALL DEVICES WERE PLACED APPROACHING FROM THE LEFT FEMORAL ARTERY FOR ABDOMINAL EVAR. ON (B)(6), A DEALER INFORMED MEDICO'S HIRATA OF THE OCCLUSIONS PROBLEM DUE TO THROMBOSIS. REGARDING THE LEFT LEG, THE OCCLUSION DUE TO THROMBOSIS WAS CONFIRMED FROM THE BIFURCATION OF THE MAIN BODY TO THE DISTAL PART OF THE EXTERNAL ILIAC ARTERY. REGARDING THE RIGHT LEG, APPROXIMATELY HALF OF THE GRAFT FROM THE CONTRA-LATERAL LEG WAS CONSTRICTED IN SIZE. BUT THE RING STENT ITSELF WAS FULLY EXPANDED. ADDITIONAL PROCEDURE: SURGICALLY, A THROMBECTOMY WAS CONDUCTED. AFTER THE CUTDOWN, ACT VALUE WAS MEASURED. WITH A UNIT OF 11,000 INTRAVENOUS INJECTION WAS CONDUCTED AND ACT VALUE SHOWED 237. ABOUT EVERY 30 MINUTES, ADDING IT WITH A UNIT OF 1500, AND FINALLY, THE ACT VALUE SHOWED 228 AFTER APPROXIMATELY ONE HOUR. THE PROCEDURE WAS FINISHED. ANATOMY: PROXIMAL NECK ANGULATION: 131 DEGREE. OUTSIDE THE IFU. PHYSICIAN'S COMMENT: IT IS DIFFICULT TO IDENTIFY A CAUSE OF THIS EVENT. IT IS ASSUMED THAT IT MIGHT BE BECAUSE OF THE PATIENT'S BLOOD COAGULATION DISORDERS. IMPLANTS USED IN THIS CASE: MODEL NUMBER, LOT NUMBER, EXPIRY DATE, MANUFACTURE DATE, UDI: SG-HBB-24-111-80-12, CP62409-1, 04 JUN 2017, 04 JUN 2015, (B)(4); SG-HBL-73-10, CL65069-1, 21 JUL 2017, 21 JUL 2015, (B)(4); SG-HBL-106-10, CL65864-1, 18 AUG 2017, 18 AUG 2017, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43799 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-24-111-80-12 CP62409-1 05055715606493

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention