BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5633695 · Received May 5, 2016

    Report

    Report Number
    3004753364-2016-00012
    Event Type
    Injury
    Date Received
    May 5, 2016
    Report Date
    April 29, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    05055715606851
    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-90-12, LOT NO. CL64290-1, MANUFACTURE DATE. 22 JUNE 2015, EXPIRY DATE. 21 JUNE 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

    EVAR WAS PERFORMED ON (B)(6) 2016. DATE EVENT OCCURRED HAS BEEN SUPPLIED AS THE 4TH WEEK OF (B)(6) 2016 (NO SPECIFIC DATE HAS BEEN GIVEN). LIMB OCCLUSION (OCCURRED POST PROCEDURE) / RE-INTERVENTION THE PHYSICIAN PERFORMED THE PROCEDURE FOLLOWING THE IFU AND FINISHED IT WITHOUT ISSUES. SG-HBB WAS IMPLANTED IN THE ABDOMINAL AORTA BY THE RIGHT COMMON ILIAC ARTERY APPROACHING. SG-HBL-90-14 WAS PLACED IN THE CONTRA-LATERAL LEG. SG-HBL-90-12 WAS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY TOWARD THE RIGHT EXTERNAL ILIAC ARTERY. AFTER THE PROCEDURE, THE PHYSICIAN TALKED WITH THE PATIENT OVER THE TELEPHONE AND KNEW THAT HE HAD CLAUDICATION. THE CT REVEALED THAT SOME THROMBOTIC OCCLUSION EXISTED FROM THE RIGHT COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. RE-INTERVENTION: IN THE WEEK OF (B)(6) 2016, THE PATIENT WILL VISIT THE HOSPITAL AND THE PHYSICIAN IS PLANNING TO PERFORM FEM-FEM BYPASS FOR HIM. LOMBARD MEDICAL REPRESENTATIVE HAS ADVISED THAT A 12MM DIAMETER STENT GRAFT WAS USED IN AN EXTERNAL ILIAC ARTERY WITH DIAMETER OF 8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291087 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-24-81-80-12 CP62158-1 05055715606851

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention