BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3808095 · Received December 5, 2013

    Report

    Report Number
    2031527-2014-00152
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    November 25, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT WAS INCONCLUSIVE. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION, BUT WHEN THE DEVICE WAS EXPLANTED; THE EXPLANTED GRAFTS DID NOT EXHIBIT ANY SIGN OF INFECTION. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS WERE CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED INFECTION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L INFO BECOMES AVAILABLE. CORRECTION: (B)(6) MFR REPORT # 2031527-2013-00333 TO (B)(6) MFR REPORT: 2131527-2014-00152.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX 1 MONTH POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PT PRESENTED WITH ABDOMINAL PAIN DUE TO INFECTION. REPORTEDLY, THE PT PRESENTED WITH CONTAINED RUPTURE AND MYCOTIC ANEURYSM DURING THE INITIAL IMPLANT. THE PHYSICIAN CHOSE TO CONVERT THE PT TO OPEN REPAIR AND TREAT THE PT WITH AXILLO BIFEMORAL BYPASS. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDURE WELL. ADD'L INFO: THE PT PRESENTED WITH INFECTED AORTA DURING THE INITIAL PROCEDURE. THE EXPLANTED GRAFTS DID NOT EXHIBIT ANY SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632268 AFX SYSTEM BIFURCATED INFRARENAL STENT GRAFT MIH ENDOLOGIX, INC. BA22-70/116-30 1047028-004

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention