BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5010427 · Received August 14, 2015

    Report

    Report Number
    2031527-2015-00319
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    1

    Narratives

    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 INFO BECOMES AVAILABLE. ADDITIONAL DEVICES: MODEL: A34-34/C100-O20; SUPRARENAL AORTIC EXTENSION; LOT: 1050126-017; RELEASE DATE: 07/10/2012; EXPIRATION DATE: 05/30/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT INITIAL IMPLANT WAS ON (B)(6) 2012. REPORTEDLY, THE PT DEVELOPED A POSSIBLE ENDOLEAK. A COMPUTED TOMOGRAPHY SCAN REVEALED ABNORMAL LOBULAR ENHANCEMENT SEEN AT THE LEFT POSTEROLATERAL PERIPHERY OF THE ENDOGRAFT REPAIR IN THE ANEURYSM SAC. NO CLEAR LEAK ORIGIN IS IDENTIFIED AND THE LOCATION MAY SUGGEST A TYPE III ENDOLEAK RATHER THAN A TYPE II ENDOLEAK. SINCE THE AAA HAS NOT INCREASED IN SIZE THE PHYSICIAN HAS ELECTED TO RESCAN AND EVALUATE IN THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539833 AFX BIFURCATED MIH ENDOLOGIX, INC. BA28-80/I16-40 1050698-010

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR