BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITRAK

    MDR report key: 5078405 · Received September 15, 2015

    Report

    Report Number
    2031527-2015-00366
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 15, 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.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL FINDINGS, THERE WAS NO EVIDENCE TO SUPPORT THE REPORTED TYPE IIIA ENDOLEAK ALTHOUGH A DECREASE IN OVERLAP WAS SIGNIFICANT. THE INTERMITTENT APPEARANCE OF AN ENDOLEAK BETTER SUPPORTED A TYPE II ENDOLEAK. REPORTEDLY, 52 MONTHS POST IMPLANT, THE PATIENT UNDERWENT A SECONDARY PROCEDURE FOR WHICH AN ADDITIONAL INFRARENAL STENT WAS PLACED; THE PATIENT WAS DOING WELL. THE PROCEDURE, ITS TECHNICAL SUCCESS, AND THE FINAL PATIENT DISPOSITION COULD NOT BE ESTABLISHED DUE TO LACK OF INFO. A MANUFACTURING RECORD REVIEW WAS PERFORMED. THE LOTS MET ALL RELEASE CRITERIA PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, AN INFRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS. UPON FOLLOW UP, COMPUTED TOMOGRAPHY REVEALED AN OVERLAP LOSS BETWEEN THE BIFURCATED AND THE INFRARENAL EXTENSION. PHYSICIAN ALSO NOTED THAT THE AORTIC ANEURYSM HAD INCREASED IN SIZE TO 5 CM FROM ORIGINAL SIZE OF 4.1 AND RIGHT COMMON ILIAC ANEURYSM HAD INCREASED IN SIZE BY 4 MM TO 5.4 FROM 5.0. PHYSICIAN DETERMINED SEVERAL POSSIBLE POTENTIAL LEAK SITES HOWEVER, THE MOST LIKELY COULD BE A TYPE 3A LEAK DUE TO LOSS OF JUNCTIONAL OVERLAP OR TYPE 3B CAUSED BY PALMAZ. PHYSICIAN HAS ELECTED TO HAVE A SECONDARY SCHEDULED FOR (B)(6) 2015 TO ADDRESS THE LOSS OF OVERLAP TO LESS THAN 15MM EVEN THOUGH A LEAK HAS NOT BEEN DETECTED. BEFORE PROCEDURE, A COMPUTED TOMOGRAPHY WILL BE PERFORMED AGAIN TO CONFIRM THAT A LEAK IS NOT PRESENT. PATIENT HAS NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608070 INTUITRAK BIFURCATED MIH ENDOLOGIX, INC. 28-16-100BL W10-4102-012

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR