BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 8723630 · Received June 21, 2019

    Report

    Report Number
    2031527-2019-00286
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE COMPLETION OF THE CLINICAL EVALUATION AND BASED ON THE INFORMATION RECEIVED, THERE WAS SUBSTANTIAL EVIDENCE TO SUPPORT THE REPORTED TYPE 1A ENDOLEAK AND SECONDARY ENDOVASCULAR PROCEDURE FROM MEDICAL RECORDS. PROCEDURE-RELATED HARMS AND DEVICE, USER, PROCEDURE, OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED. IN ADDITION, NO CONTRIBUTING FACTORS COULD BE IDENTIFIED DUE TO THE LACK OF THE RELEVANT MEDICAL IMAGES SURROUNDING THE REPORTED EVENT. THE FINAL PATIENT IS REPORTED TO BE STABLE. THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THESE TYPES OF EVENTS WILL BE MONITORED AND TRENDED AS PART OF THE QUALITY SYSTEM.

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER TIME THAT IS PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED. DEVICE ITERATION IS AFX WITH STRATA.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS DETECTED DURING ROUTINE FOLLOW-UP. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH THE OVATION IX SYSTEM (ONE (1) MAIN BODY AND FOUR (4) ILIAC LIMBS) ON (B)(6) 2019. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518223 AFX SUPRARENAL AORTIC EXTENSION MIH ENDOLOGIX A25-25/C95-O20 W11-4917-018

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention AFX BIFURCATED STENT GRAFT: LOT W11-4890-008| AFX BIFURCATED STENT GRAFT: LOT W11-4890-008