BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 3345877 · Received September 12, 2013

    Report

    Report Number
    2015691-2013-21054
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. IN THIS CASE, THE TEARING OF THE NATIVE LEAFLET APPEARS TO BE A COMPLICATION OF THE PROCEDURE. THERE WERE NO MALFUNCTIONS OR DEFICIENCIES OF THE EDWARDS DEVICES. NO CORRECTIVE ACTIONS ARE REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE, DURING BAV, THE ANTERIOR LEAFLET OF THE NATIVE VALVE WAS EVULSED CAUSING SIGNIFICANT AI WITHOUT ANY HEMODYNAMIC COMPROMISE. WHILE ADVANCING THE RF3 DELIVERY SYSTEM, THE ANTERIOR LEAFLET WAS DISLODGED INTO THE APEX. THE VALVE WAS DEPLOYED WITHOUT ANY ISSUES AND THE DELIVERY SYSTEM WAS REMOVED. CLOSURE OF THE RIGHT AND LEFT FEMORAL ARTERIES WITH PERCLOSE WAS PERFORMED WITH NO VASCULAR ISSUES. IT WAS CONFIRMED THAT THE LEAFLET WAS NOT REMOVED FROM THE PATIENT, BUT ACCORDING TO THE TEAM, THE LEAFLET WILL HOPEFULLY JUST EMBED ITSELF INTO THE MYOCARDIUM AND PROBABLY THROMBOSE. THE PATIENT WAS DISCHARGED OVER THE WEEKEND AND WAS DOING WELL WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457943 EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26 59450588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention