BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4360191 · Received December 17, 2014

    Report

    Report Number
    3004753364-2014-00021
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    October 20, 2014
    Report Date
    December 18, 2014
    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

    UDI#: ((B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE CONTRALATERAL LEG LENGTH SHOULD HAVE BEEN 56MM AND NOT 73MM AS DEMANDED BY THE PHYSICIAN. THE OVERSIZING AND MISPLACEMENT OF THE CONTRALATERAL LEG MAY HAVE CONTRIBUTED TO THE LIMB OCCLUSION. THE IFU STATES: "EACH STENT GRAFT MUST BE ORDERED IN A SIZE APPROPRIATE TO FIT THE PATIENT'S ANATOMY. PHYSICIANS SHOULD USE ADEQUATE DIAGNOSTIC TECHNIQUES, INCLUDING CT IMAGING TO EVALUATE FULLY THE INDIVIDUAL NEEDS OF THE PATIENT". NO FURTHER UPDATES REQUIRED. THE RISK MGMT FILE WAS REVIEWED AND INTERNAL ILIAC OCCLUSION IS LISTED IN THE HAZARD ANALYSIS UNDER SECTION C.4.2. - MISPLACEMENT OF CONTRA-LATERAL LIMB. NO FURTHER UPDATE IS REQUIRED. THERE IS NO INFO IS SUGGEST THE DEVICE HAS NOT WORKED AS INTENDED.

    Description of Event or Problem · 1

    DURING THE ORIGINAL PROCEDURE PERFORMED ON (B)(6), THE LEFT INTERNAL ILIAC ARTERY WAS OCCLUDED. ALTHOUGH THE WORKING LENGTH WAS 65MM, THE CLINICIAN STRONGLY DEMANDED A 73MM LEG, INSTEAD OF A 56CM THAT WAS RECOMMENDED. THE PHYSICIAN TRIED TO PUSH UP THE CONTRALATERAL LEG BY USING A BALLOON, BUT NO SUCCESS. THE PATIENT WAS CLOSELY MONITORED AND THE PHYSICIAN OPTED TO WITHHOLD A TREATMENT. UPON COMPLETION OF THE PROCEDURE, THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. IMPLANTED DEVICES: 1). SG-HBB-24-81; LOT: BW486001-1; EXP. DATE: 03/19/2016; MFR DATE: MAR 2014. 2) SG-HBL-73-16; LOT: BZ49080-1; EXP. DATE: 05/05/2016; MFR DATE: MAY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829345 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD SG-HBB-24-81 BW48600-1

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Disability