BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5053626 · Received September 3, 2015

    Report

    Report Number
    2031527-2015-00348
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE IIIB ENDOLEAK WAS CONFIRMED. 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 AND THEREFORE, IDENTIFICATION OF A DESIGN OR MANUFACTURING ISSUE IS INCONCLUSIVE. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME: MISUSE OF THE DEVICE DUE TO THE RIGHT COMMON ILIAC ARTERY ANEURYSM DIAMETER OF GREATER THAN 2.3 CM, PATENT LUMBAR ARTERIES AND INFERIOR MESENTERIC ARTERY, AS WELL AS A SHORT SEGMENT DISSECTION IN THE MID AORTA THAT PROVIDED A CALCIFIED BLOOD LUMEN; AND THERE WAS A NEW NON-ENDOLOGIX LEFT LIMB EXTENSION WITH THE LEFT COMMON ILIAC ARTERY WITH SUBOPTIMAL OVERLAP. IT COULD NOT BE DETERMINED WHEN AND FOR WHAT REASON THIS ADDITIONAL SECONDARY NON-ENDOLOGIX DEVICE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANEURYSM IS GROWING SINCE INDEX PROCEDURE ON (B)(6) 2011 WITH A POTENTIAL TYPE 3B ENDOLEAK. THE PATIENT IS DOING WELL, AND NO PLANS TO CORRECT THE ENDOLEAK AS OF NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586541 AFX BIFURCATED MIH ENDOLOGIX, INC. BA25-70/I16-30 W11-4724-009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention