BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5010424 · Received August 14, 2015

    Report

    Report Number
    2031527-2015-00320
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE IB ENDOLEAK WAS CONFIRMED AND THE POSSIBLE TYPE IIIA AND TYPE IIIB WAS CONFIRMED AS A TYPE IIIB ENDOLEAK ALTHOUGH THE DEVICE REMAINS IN THE PATIENT AT THIS TIME. 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 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, A ROOT CAUSE WAS NOT DEFINITELY IDENTIFIED. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME. THE BILATERAL ILIAC ARTERY ANEURYSMS GREATER THAN 2 3 CM IN DIAMETER MAY HAVE CONTRIBUTED TO THE TYPE IB ENDOLEAK. THE ROOT CAUSE OF THE POSSIBLE TYPE III B ENDOLEAK WAS NOT IDENTIFIED.

    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 INFO BECOMES AVAILABLE. ADDITIONAL DEVICES: (B)(4) SA LIMB EXTENSION, LOT 1250463-010. RELEASE DATE: 06/05/2015. EXPIRATION DATE: 04/30/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL PROCEDURE IT WAS POSSIBLE A COMPONENT SEPARATION, AND TEAR IN THE BIFURCATED OCCURRED. REPORTEDLY, THE PHYSICIAN FIRST PLACE A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION. AN ANGIO WAS THEN DONE AND SHOWED A DISTAL ENDOLEAK ON THE LEFT SIDE. THEREFORE, THE PHYSICIAN PLACED ANOTHER LIMB EXTENSION AND ANOTHER ANGIO WAS DONE AND SHOWED A LEAK. A CODA WAS THEN USED ON THE OVERLAPS AND THERE STILL WAS A LEAK. AFTER OCCLUDING THE LEFT LIMB AND STILL SEEING A LEAK, IT WAS DETERMINED THAT A SECOND MAIN BODY NEEDED TO SEAL. A MAIN BODY WAS THEN PLACED AND THE LEAK WAS NOT PRESENT ON THE FINAL RUN. PT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540687 AFX BIFURCATED MIH ENDOLOGIX, INC. BA25-80/I20-40 1251879-014

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention