BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4683739 · Received April 9, 2015

    Report

    Report Number
    3004753364-2015-00009
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    February 25, 2015
    Report Date
    April 10, 2015
    Manufacturer
    LOMBARD MEDICAL LTD
    Product Code
    MIH
    PMA / PMN Number
    P110032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DHR REVIEW: A FULL REVIEW OF THE DEV ICE HISTORY RECORD FOR THIS DEVICE HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; THE PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE HAS NOT MET THE FINAL RELEASE CRITERIA. VIDEO REVIEW: ADDITIONALLY REVIEW OF AN IN PROCESS VIDEO TAKEN AFTER LOADING OF THE MAIN BODY AND PROXIMAL EXTENDER DEVICES WAS REVIEWED. THIS VIDEO ACTS AS A RECORD THAT THE DEVICE MEETS THE INSPECTION REQUIREMENTS FOR A LOADED IMPLANT. THIS VIDEO CONFIRMED THAT THE DEVICES WERE PACKED INTO THE DELIVERY SYSTEMS IN ACCORDANCE TO COMPANY WORK INSTRUCTION 211, INSPECTION OF PACK SG-HBB AND SG-HPE DEVICES. AN INVESTIGATION HAS BEEN STARTED AND A FOLLOW-UP REPORT SHALL BE FILED UPON CONCLUSION.

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2014. THE PHYSICIAN STATES HE HAD OVERLOOKED A TYPE LB ENDOLEAK IN THE ORIGINAL PROCEDURE. THE PATIENT WAS FOLLOWED-UP ON THE (B)(6) 2015 AND, ACCORDING TO THE PHYSICIAN, THERE IS A POSSIBLE TYPE LA ENDOLEAK. ON THE (B)(6) 2015 A RE-INTERVENTION WAS PERFORMED TO IMPLANT A STENT-GRAFT LEG IN ORDER TO SOLVE THE TYPE LB ENDOLEAK AND A COMPETITOR PROXIMAL EXTENDER TO SOLVE THE POSSIBLE TYPE LA ENDOLEAK. THE PATIENT WAS DISCHARGED AND WILL BE FOLLOWED-UP AS PER STANDARD PROCEDURE. THE MANUFACTURER WAS MADE AWARE OF THIS CASE ON THE 13-MAR-2015. MODEL#: SG-HBB-31-96, LOT# BW48884-1, EXPIRY DATE: 30 APR 2016, MANUF DATE: APR 2014. MODEL#: SG-HPE-31-38, LOT# BY48547-1, EXPIRY DATE: 17 MAR 2016, MANUF DATE: MAR 2014. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233571 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD SG-HBL-56-18 BZ50256-1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention