BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5061655 · Received September 8, 2015

    Report

    Report Number
    2031527-2015-00351
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    June 13, 2015
    Report Date
    June 16, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT HAS BEEN DETERMINED INCONCLUSIVE. THERE WERE NO IMAGES/RECORDS AVAILABLE FOR EVALUATION. THE DEVICES WERE EXPLANTED BUT WERE NOT AVAILABLE FOR EVALUATION A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAVE BEEN CONSUMED AND NO OTHER UNITS FROM THIS LOT 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, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. ADDITIONAL DEVICES: MODEL BA28-90/I16-30, LOT: 1043311-008, RELEASE DATE: 5/16/2015, EXPIRATION DATE: 3/31/2015. MODEL A34-34/C100-O20, LOT: 1031801-028, RELEASE DATE: 3/28/2012 . EXPIRATION DATE: 2/28/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL EMERGENCY ROOM WITH UNKNOWN SYMPTOMS. THE HOSPITAL PERFORMED A COMPUTED TOMOGRAPHY SCAN WHICH INDICATED THE PATIENT HAD AN ENDOLEAK (COMPONENT SEPARATION BETWEEN THE BIFURCATED DEVICE AND THE INFRARENAL AORTIC EXTENSION). THE PHYSICIAN ELECTED TO CORRECT THE ENDOLEAK BY EXPLANTING THE DEVICES DUE TO THE DIFFICULTY NATURE OF THE CASE. THE PATIENT WAS REPORTED TO BE DOING OK POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593634 AFX INFRARENAL AORTIC EXTENSION MIH ENDOLOGIX, INC. A34-34/C100 W11-2806R-001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention