BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 5082260 · Received September 16, 2015

    Report

    Report Number
    2031527-2015-00370
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 19, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE 1A, 1B AND 3B HAVE BEEN CONFIRMED. THE DEVICES REMAIN IN THE PATIENT. BASED UPON THE INVESTIGATION, AN EXACT ROOT CAUSE WAS NOT IDENTIFIED DUE TO THE LIMITED AVAILABLE INFORMATION. PATIENT FACTORS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED THE USE OF ANTICOAGULATION THERAPY (COUMADIN). OVERALL, IDENTIFICATION OF A DESIGN OR MANUFACTURING ISSUE IS INCONCLUSIVE.

    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. ADDITIONAL DEVICE: MODEL A34-34/C80 INFRARENAL AORTIC EXTENSION LOT #:1029313-004 RELEASE DATE: 2/16/2012 EXPIRATION DATE: 12/30/2012 MODEL A34-34/C100-O20 SUPRARENAL AORTIC EXTENSION LOT#1031801-020 RELEASE DATE: 3/28/2012 EXPIRATION DATE: 2/28/2013, DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED, A INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. UPON FOLLOW UP, COMPUTED TOMOGRAPHY REVEALED THAT THE AAA HAD INCREASED IN SIZE BY 1CM AND THERE WAS AN ENDOLEAK. ANGIOGRAM LOOKED LIKE THERE WAS A PROXIMAL ENDOLEAK AND POSSIBLE A DISTAL ENDOLEAK OR A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT TWO SUPRARENAL AORTIC EXTENSIONS AT LEVEL OF RENAL ARTERIES, ONE INFRARENAL AORTIC EXTENSION IN THE BIFURCATED GRAFT AND ONE LIMB EXTENSION INTO THE RIGHT COMMON ILIAC. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614233 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-80/I16-40 W11-3814-008

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention