BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5200658 · Received October 29, 2015

    Report

    Report Number
    2031527-2015-00429
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES REMAIN IMPLANTED. THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL DEVICE: A28-28/C95-O20 V, LOT: 1252419-052, RELEASE DATE: (B)(6) 2015 AND EXPIRATION DATE: 06/11/2018.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, A TYPE IIIB ENDOLEAK AT THE IMPLANT, A PERSISTENT TYPE IA ENDOLEAK, AND THE FINAL DISPOSITION OF THE PT COULD NOT BE ESTABLISHED DUE TO LACK OF INFO. A MFG RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. A DESIGN OR MFG ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFO, AND OVERALL THE INVESTIGATION IS INCONCLUSIVE. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO THE STENOSIS OF THE RIGHT ILIAC ARTERY (9 MM). CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED THE MODERATE SEVERE CALCIFICATIONS AT THE BIFURCATION AND BILATERAL ILIAC ARTERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, UPON PLACEMENT OF THE BIFURCATED, AN INFRARENAL, AND SUPRARENAL, PHYSICIAN NOTED A JETTING FLOW NEAR THE IMPLANTED DEVICES AND IT WAS DETERMINED TO BE A POSSIBLE 3B ENDOLEAK AND PROXIMAL ENDOLEAK. THE PHYSICIAN ELECTED TO RELINED WITH A SECOND BIFURCATED TO RESOLVE THE POSSIBLE 3B ENDOLEAK AND BRING BACK THE PATIENT AT LATER TIME TO FIX THE PROXIMAL ENDOLEAK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718026 AFX MIH ENDOLOGIX BA25-90/I16-30 1252264-017

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR