BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5047896 · Received September 1, 2015

    Report

    Report Number
    2031527-2015-00343
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 3, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION BECOMES AVAILABLE. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE IIIB ENDOLEAK WAS CONFIRMED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAD BEEN CONSUMED AND NO OTHER UNITS FROM THIS LOT WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. 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: MISUSE OF THE DEVICE DUE TO THE RIGHT COMMON ILIAC ARTERY ANEURYSM DIAMETER OF GREATER THAN 2.3 CM, AN AORTIC NECK LENGTH OF LESS THAN 15MM; AND AORTIC NECK DIAMETER CHANGE OF 30 PERCENT. ADDITIONAL FACTORS INCLUDED: A TORTUOUS RIGHT COMMON ILIAC ARTERY (NEAR 90 DEGREES); MODERATE CALCIFICATIONS WITHIN THE ILIAC ARTERIES; AND PATIENT USE OF ANTICOAGULATION TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION. THE PATIENT HAD AN ANNUAL FOLLOW UP, AND THE COMPUTED TOMOGRAPHY NOTED A LEAK. THE PATIENT WAS THEN REFERRED TO ANGIO LAB FOR SELECTIVE RUN OFFS TO DETERMINE WHERE LEAK WAS COMING FROM. THE SELECTIVE ANGIO DEMONSTRATES WHAT APPEARS TO BE A TYPE 3B MATERIAL LEAK AT BIFURCATION. THE PHYSICIAN HAS SCHEDULED THE PATIENT TO HAVE HIS GRAFT RELINED WITH A NEW BIFURCATED GRAFT ON (B)(6) 2015

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579471 AFX BIFURCATED MIH ENDOLOGIX, INC. BA28-60/I16-40 W11-3388-009

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR