BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA STENT GRAFT

    MDR report key: 5597379 · Received April 22, 2016

    Report

    Report Number
    3004753364-2016-00011
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 20, 2016
    Manufacturer
    LOMBARD MEDICAL LTD.
    Product Code
    MIH
    UDI-DI
    05055715631365
    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-73-20 / SG-HBL-56-20, LOT NO. BZ55668-1 / CL61529-1, MANUFACTURE DATE. 14 OCT 2014 / 27 MAR 2015, EXPIRY DATE.13 OCT 2016 / 26 MAR 2017. DISTAL EXTENDER INFORMATION: MODEL NO. SG-HDE-12-51, LOT NO. CM61173-1, MANUFACTURE DATE. 07 APR 2015, EXPIRY DATE. 06 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

    TYPE III ENDOLEAK OF IPSI-LATERAL LIMB (AFTER THE PROCEDURE). ON (B)(6) 2015, A HBB-31 (MAIN BODY) AND A HBL-73 (CONTRA-LATERAL LIMB) WERE PLACED. AT THAT TIME, A TYPE IV ENDOLEAK AND TYPE II ENDOLEAK WERE REVEALED AND THE PROCEDURE WAS FINISHED. NOT BEING SEEN ANY CHANGES IN THE DIAMETER OF ANEURYSM EVEN 10 MONTHS HAVE PASSED AFTER THE PROCEDURE, THE PHYSICIAN SUSPECTED ANOTHER TYPE OF ENDOLEAKS. ON (B)(6) 2016, THE PHYSICIAN PERFORMED A CONTRAST-ENHANCED CT (4D) AND ASSUMED THAT IT MIGHT BE A TYPE III ENDOLEAK COMING FROM THE JUNCTION PORTION OF THE CONTRA-LATERAL LIMB. THEREFORE, HE MOULDED A BALLOON CATHETER AROUND THE JUNCTION PORTION OF THE LEFT LEG AND ADDED A GRAFT (HDE-12-51), BUT STILL NO CHANGE IN ENDOLEAKS. THUS, THE PHYSICIAN SELECTIVELY PERFORMED CT ON THE LEFT IPSI-LATERAL LIMB AGAIN AND CONFIRMED A DEFINITE ENDOLEAK, ALTHOUGH IT WAS NOT IDENTIFIED WHICH TYPE OF ENDOLEAK IT WAS. SUSPECTING POSSIBILITIES OF SEVERAL PERFORATIONS IN THE DEVICE, THE PHYSICIAN PLACED AN ADDITIONAL DEVICE (HBL-56-20) TO COVER THE WHOLE IPSI-LATERAL LIMB. THEN, THE ENDOLEAK DISSOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252416 AORFIX AAA STENT GRAFT ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD. SG-HBB-31-96-80-18 BW51836-1 05055715631365

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention