BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3408711 · Received October 14, 2013

    Report

    Report Number
    2031527-2013-00254
    Event Type
    Death
    Date Received
    October 14, 2013
    Date of Event
    September 14, 2013
    Report Date
    September 14, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY MEDICAL DIRECTOR. BASED ON REVIEW OF THE INFORMATION PROVIDED, THE EXACT TYPE AND SOURCE OF ENDOLEAK COULD NOT BE DETERMINED. HOWEVER, THERE IS INDICATION OF TYPE II ENDOLEAK, WHICH IS NOT DEVICE RELATED. CONTINUAL LEAKAGE FROM A TYPE II ENDOLEAK COULD EXPLAIN THE SAC EXPANSION AND SUBSEQUENT RUPTURE. THERE WAS NO INDICATION OF ANY PRODUCT DEFECTS OR ISSUES. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES AND DEVIATIONS THAT EXPLAIN THE REPORTED EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN SIMILAR EVENT.

    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 ADDITIONAL INFORMATION BECOMES AVAILABLE. REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 30 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION THE PATIENT EXPIRED DUE TO A RUPTURE. REPORTEDLY, THE PHYSICIAN IDENTIFIED AN ENDOLEAK (APPROXIMATELY 23 MONTHS) THAT COULD NOT BE RESOLVED WITH A PALMAZ STENT AND AN INFRARENAL AORTIC EXTENSION. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND MONITOR THE PATIENT (2031527-2013-00147). REPORTEDLY, THE PHYSICIAN BELIEVED TO BE A TYPE II ENDOLEAK. APPROXIMATELY 4 MONTHS LATER, THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH BACK PAIN AND HYPOTENSIVE. A COMPUTED TOMOGRAPHY SCAN (CT) REVEALED A RUPTURE, POSSIBLY DUE TO A TRANSGRAFT LEAK OR TYPE I ENDOLEAK. THE NEXT DAY, THE PATIENT EXPIRED DUE TO A RUPTURE. THE PATIENT WAS NOT TAKEN TO THE OPERATIVE ROOM AND NO INTERVENTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525303 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80 1025806-009

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death