BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIFLEX

    MDR report key: 5263443 · Received November 30, 2015

    Report

    Report Number
    2031527-2015-00468
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    October 31, 2015
    Report Date
    October 29, 2015
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. MODEL # AND LOT # OF OTHER INVOLVED DEVICE: MODEL#: 28-28-75L, INT'L VISTIFLEX; LOT #: W08-0803-014; DOM: (B)(6) 2008; EXPIRATION: 04/30/2011.

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED TYPE IIIIA ENDOLEAK WAS CONFIRMED. THERE WAS ALSO EVIDENCE OF COMPLETE COMPONENT SEPARATION. THE MANUFACTURING RECORD REVIEW DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. BASED UPON THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DEFINITELY DETERMINED ALTHOUGH PATIENT ANATOMY WAS THE LIKELY CAUSE OF COMPONENT SEPARATION AND THE RESULTING ENDOLEAK. THERE WAS NO DESIGN OR MANUFACTURING ISSUE IDENTIFIED. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTORS THAT MAY HAVE BEEN CONTRIBUTORS TO THE EVENT: THE REPORTED 90° ANGULATION OF THE INFRARENAL AORTA; THE INABILITY TO TOLERATE CONTRASTED SURVEILLANCE (SOME FOLLOW-UP STUDIES DID NOT INCLUDE CONTRAST); THE USE OF CONCOMITANT NON-ENDOLOGIX BARE METAL STENTS WITHIN THE PROXIMAL AORTA; AND THE USE OF ANTIPLATELET THERAPY (ASPIRIN AND PLAVIX).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2008 WITH A BIFURCATED AND TWO CUFF STENT GRAFTS. REPORTEDLY, THE PATIENT EXPERIENCED PAIN IN THE LEFT LEG COMPUTED TOMOGRAPHY REVEALED AN ENDO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785021 VISIFLEX STENT GRAFT MIH ENDOLOGIX 28-28-75L-US VISIFLEX W08-0023-006

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention