BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7301028 · Received February 27, 2018

    Report

    Report Number
    2031527-2018-00125
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 2, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST A TYPE IIIB ENDOLEAK OCCURRED THAT WERE NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE IIIB ENDOLEAK WAS DISCOVERED ON 06/08/2018 DURING REVIEW OF THE 46 MONTH ANGIOGRAM. CLINICAL EVALUATIONS WAS UNABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED TYPE IIIA. THE MOST LIKELY CAUSE OF THE COMPROMISED STENT GRAFT INTEGRITY, TYPE IIIBWAS THE USE OF THE STRATA MATERIAL. TO DATE THERE HAS BEEN NO REPORTS OF FURTHER NEGATIVE PATIENT SEQUALAE. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE MANUFACTURING RECORD REVIEW DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWS ONE COMPLAINT: (B)(4) INVOLVING LOT#: 1100966 WITH A TYPE IIIB ENDOLEAK. THERE WERE NO OTHER UNITS FROM THE AFFECTED LOTS THAT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED THEREFORE NO EVALUATION WAS COMPLETED A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE IIIB ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE IIIB ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE JULY 2014. THE TYPE IIIB ENDOLEAK RATE FOR AFX MANUFACTURED AND IMPLANTED BEFORE THESE CORRECTIVE ACTIONS WERE PUT IN PLACE IS TRENDING AT 2.5%. SINCE THE CORRECTIVE ACTIONS WERE IMPLEMENTED, THE TYPE IIIB ENDOLEAK EVENTS REPORTED FOR AFX DEVICES HAS BEEN REDUCED TO <0.2%. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. CORRECTION : DEVICE EXPIRATION IS 06/30/2016.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 02/05/2018, ENDOLOGIX WAS MADE AWARE FROM A REP THAT A PATIENT HAD A TYPE 3A ENDOLEAK AND HAD A SECONDARY PROCEDURE (RE-LINE) ON (B)(6) 2018 WITH A NON-ENDOLOGIX DEVICE (GORE) AT THE (B)(6) HOSPITAL BY DR. (B)(6). PATIENT INITIAL IMPLANT WAS DONE ON (B)(6) 2014 AT NORTHWEST MEDICAL CENTER BY DR. (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142386 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. BA25-90/I20-30 1100966-037

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SUPRARENAL EXTENSION, LOT 1203546026| SUPRARENAL EXTENSION, LOT 1203546026