BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT

    MDR report key: 5789084 · Received July 13, 2016

    Report

    Report Number
    3004753364-2016-00021
    Event Type
    Death
    Date Received
    July 13, 2016
    Date of Event
    June 22, 2016
    Report Date
    July 12, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    05055715611893
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PRODUCT USED: PLUG-IN LEG INFORMATION: MODEL NO. SG-HBL-56-12, LOT NO. CL60954-1, MANUFACTURE DATE. 17 MARCH 2015, EXPIRY DATE. 16 MARCH 2017. PROXIMAL EXTENDER INFORMATION: MODEL NO. SG-HPE-31-38, LOT NO. CQ59955-1, MANUFACTURE DATE. 18 FEBRUARY 2015, EXPIRY DATE. 17 FEBRUARY 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. FROM A REVIEW OF THE PATIENT'S ANATOMY, THE PROXIMAL NECK IS HIGHLY ANGULATED. THE PHYSICIAN HAS STATED THAT DUE TO THE FIRST TIME USE OF THE PRODUCT, IT WAS DIFFICULT TO LAND THE PROXIMAL EXTENDER AS IT IS SHORT IN LENGTH. REVIEW OF THE PATIENT SCANS IDENTIFIED ANATOMICAL ISSUES AND CONCERNS REGARDING DEVICE SELECTION.

    Description of Event or Problem · 1

    ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2016. AFTER PLACING THE MAIN BODY AND A CONTRA-LATERAL LIMB, THE PHYSICIAN INFLATED A BALLOON CATHETER. THE FINAL ANGIOGRAPHY REVEALED A TYPE 1A ENDOLEAK IN THE PROXIMAL PORTION. THE PHYSICIAN RE-BALLOONED, HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN PLACED A PROXIMAL EXTENDER (SG-HPE), HOWEVER THE ENDOLEAK STILL REMAINED. FINALLY, AN ENDURANT CUFF (MEDTRONIC) WAS IMPLANTED. ON FINAL RUN, THE TYPE 1A AND TYPE 4 REMAINED. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS TO BE FOLLOWED-UP. UPDATE RECEIVED ON 22 JUN 2016, THE ANEURYSM HAD RUPTURED AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444933 AORFIX AAA FLEXIBLE STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-31-81-80-12 CP59770-1 05055715611893

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death