BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 5118322 · Received October 1, 2015

    Report

    Report Number
    2015691-2015-02594
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    October 14, 2014
    Report Date
    September 7, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE DEVICE WAS NOT RETURNED TO MANUFACTURER AS IT REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. WITHOUT RECEIPT OF EXPLANTED DEVICE OR ADDITIONAL INFORMATION THE REPORTED CLINICAL OBSERVATION CANNOT BE INVESTIGATED AND ROOT CAUSE CANNOT BE DETERMINED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED THROUGH EUROPEAN CONGRESS: "TRANSCATHETER VALVE-IN-VALVE (VIV) IMPLANTATION EXPERIENCE IN 5 DIFFERENT CATHETER VALVES IN THREE DIFFERENT BIOPROSTHESES". THE AUTHOR PRESENTED A RETROSPECTIVE STUDY FROM 2009 TO SEPTEMBER 2014. 642 TAVI PROCEDURES WERE PERFORMED DURING THE TIME PERIOD, IN WHICH 31 WERE VIV REPRESENTING 5% OF TOTAL CASES. THE THREE BIOPROSTHESES WERE: MITROFLOW (N=24) , PERIMOUNT MAGNA (N=6) ) AND CRYOLIFE O'BRIAN (N=1). RELATED TO THIS CONGRESS" PRESENTATION THE ARTICLE "SINGLE INSTITUTION EXPERIENCE WITH TRANSCATHETER VALVE-IN-VALVE IMPLANTATION EMPHASIZING STRATEGIES FOR CORONARY PROTECTION" AUTHOR: DANIELE CAMBONI, ET AL. PUBLISHED ON ANN THORAC SURG 2015:99:1532-8. THERE WERE 3 MAGNA SIZES INVOLVED IN THESE 6 VALVE IN VALVE, 21, 23 AND 25. IN THIS CASE A 25 MAGNA VALVE IMPLANTED IN THE PATIENT REQUIRED A VALVE IN VALVE WITH A SAPIENXT 26. AS CONFIRMED THE PERIMOUNT MAGNA DESCRIBED IN THIS ARTICLE WERE IMPLANTED 8-12 YEARS BEFORE, IN ADDITION SOME OF THESE PATIENTS HAD RENAL INSUFFICIENCY. THERE WERE NO ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646735 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R