BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3806539 · Received May 13, 2014

    Report

    Report Number
    2031527-2014-00134
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. THE PATIENT MEDICAL INFORMATION WAS REVIEWED BY CLINICAL COMPLAINT SPECIALIST WITH THE FOLLOWING INFORMATION: THERE WAS EVIDENCE OF A POSSIBLE ENDOLEAK ON THE CTA, BUT THIS COMPLAINT MIGHT BE BEST DESCRIBED AS UNKNOWN ENDOLEAK, AS REPORTED IN THE OPERATIVE REPORT; THERE WAS NO RADIOLOGICAL SUBSTANTIATION OF THIS FINDING. 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 WERE CONSUMED AND NO OTHER UNITS 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, A ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE CLINICAL REVIEW SUGGESTED THAT, DIFFICULT TO WITHDRAW DELIVERY SYSTEM WAS SUBSTANTIATED WHICH CORROBORATES THE MALFUNCTION. ALSO THERE WAS AN EVIDENCE OF DIFFICULT RETRACTION OF THE MAIN BODY DELIVERY SYSTEM AND MIGHT HAVE CONTRIBUTED TO THE STENT FRACTURE, AND MIGHT HAVE BEEN THE SOURCE OF THE UNIDENTIFIED ENDOLEAK; HOWEVER, THE PATIENT'S ANATOMY MIGHT HAVE ALSO BEEN A FACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF A BIFURCATED DEVICE, SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS, THE PHYSICIAN PERFORMED A SNORKEL PROCEDURE AND THERE APPEARED TO BE AN ENDOLEAK. AFTER IMPLANTATION A 360 IMAGING WAS PERFORMED, AND THE MAIN DISTAL AORTIC BIFURCATION FABRIC MATERIAL HAD A TEAR DUE TO AN APPARENT STENT STRUT FRACTURE. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PHYSICIAN ELECTED TO FOLLOW UP WITH THE PATIENT WITHIN 30DAYS WITH A CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286406 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT (BGI) MIH ENDOLOGIX, INC. BA25-110/I16-30 1224847-005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR