BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

    MDR report key: 4360270 · Received December 17, 2014

    Report

    Report Number
    3004753364-2014-00020
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    October 14, 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

    (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE PHYSICIAN TRIED TO RE-POSITION THE STENT GRAFT MAIN BODY AFTER THE DEPLOYMENT IS FINISHED. NO FURTHER UPDATES REQUIRED. THE RISK MGMT FILE WAS REVIEWED AND RENAL ARTERY OCCLUSION IS LISTED IN THE HAZARD ANALYSIS UNDER SECTION C.1.4. NO FURTHER UPDATE IS REQUIRED. THERE IS NO INFO TO SUGGEST THE DEVICE HAS NOT WORKED AS INTENDED.

    Description of Event or Problem · 1

    DURING THE ORIGINAL PROCEDURE PERFORMED ON (B)(6), THE LEFT RENAL ARTERY WAS OCCLUDED. THE PHYSICIAN TRIED TO PULL DOWN THE MAIN BODY BY USING A BALLOON, BUT NO SUCCESS. CANNULATION OF THE LEFT RENAL ARTERY WAS TRIED, BUT DIDN'T SUCCEEDED EITHER. PATIENT WAS FOLLOWED UP ON (B)(6) 2014 AND ACCORDING TO THE PHYSICIAN, THEIR CONDITION HAD STABILIZED SINCE CRE IS RISING TO 1.8 AND THE PATIENT WAS PRODUCING URINE, THEREFORE, NO OTHER ACTIONS WERE REQUIRED. UPON COMPLETION OF THE PROCEDURE, THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AND THE PATIENT IS PROGRESSING WELL. IMPLANTED DEVICES: SG-HBB-24-96; LOT NUMBER: BW49353-1; EXP. DATE: 04/09/2016; MFR DATE: APRIL 2014; SG-HBL-106-10; LOT: BZ48549-1; EXP. DATE: 05/06/2016; MFR DATE: MAR 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829334 AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL LTD SG-HBB-24-96 BW49353-1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Disability