BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5249952 · Received November 23, 2015

    Report

    Report Number
    2031527-2015-00464
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED EVENT IS INCONCLUSIVE; RATHER A TYPE 1B AND TYPE II ENDOLEAK WAS CONFIRMED. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. BASED UPON THE INVESTIGATION, A ROOT CAUSE WAS NOT DEFINITELY IDENTIFIED AND THEREFORE, IDENTIFICATION OF A DESIGN OR MANUFACTURING ISSUE IS INCONCLUSIVE. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME: PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: THE CUFF WAS TWO SIZES LARGER IN DIAMETER THAN THE MAIN BODY; AND, GIVEN THE OBSERVED SEVERE BILATERAL. ILIAC ARTERY ANGULATION (RIGHT 180° AND, LEFT 140 °) AT 27 MONTHS POST IMPLANT. PATIENT FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: USE OF ANTIPLATELET THERAPY (ASPIRIN). ADDITIONAL DEVICE INITIALLY IMPLANTED: MODEL: A34-34/C100-020 V SUPRARENAL AORTIC EXTENSION LOT: 1252451-014 REL. DATE: 7/17/2014 EXP. DATE: 6/20/2015.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MODEL# AND LOT# OF OTHER INVOLVED DEVICE: MODEL# IS20-25/C65 SA; LOT# 1253196-002, DOM: (B)(6) 2014; EXPIRATION: 07/22/2017;(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2014 WITH A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION. UPON FOLLOW-UP, COMPUTED TOMOGRAPHY REVEALED 3A AND 1B ENDOLEAK. PHYSICIAN ELECTED TO PLACE A SUPRARENAL AORTIC EXTENSION AND A LIMB AORTIC EXTENSION TO SEAL THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE WITH A LIMB STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION. DURING THE PROCEDURE, AN ENDOLEAK TYPE IIIA AND IB OCCURRED. THE PHYSICIAN ELECTED TO ADD A SUPRARENAL AND AN ILIAC LIMB TO CORRECT THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773528 AFX BIFURCATED MIH ENDOLOGIX, INC. BA25-120/I20-40 1111629-022

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention