BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6123590 · Received November 23, 2016

    Report

    Report Number
    2031527-2016-00553
    Event Type
    Injury
    Date Received
    November 23, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    UDI-DI
    00818009010032
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE INVESTIGATION, BASED ON LACK OF MEDICAL INFORMATION RECEIVED, THERE WAS NO EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS; TYPE IA ENDOLEAK AND SUCCESSFUL ENDOVASCULAR REPAIR. CLINICAL WAS UNABLE TO FIND EVIDENCE TO REASONABLY SUGGEST CONTRIBUTING FACTOR TO THE REPORTED EVENT DUE TO LIMITED AVAILABLE PATIENT INFORMATION. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. DEVICE WAS NOT RETURNED, THEREFORE, SAMPLE EVALUATION WAS NOT COMPLETED. UNKNOWN, THERE IS NOT ENOUGH INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT AT THIS TIME. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. CORRECTION: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2015. THE PHYSICIAN COMPLETED A SUBSEQUENT ENDOVASCULAR PROCEDURE ON (B)(6) 2016 AND IMPLANTED AN ADDITIONAL SUPRARENAL AORTIC EXTENSION TO RESOLVE AN UNKNOWN ISSUE. CURRENT PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776698 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-100/I16-40 1252305-006 00818009010032

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC- (B)(4)