BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 3963109 · Received July 29, 2014

    Report

    Report Number
    2015691-2014-01716
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT. THERE ARE EXTENSIVE MANUFACTURING INSPECTIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING PERFORMED TO EVERY MANUFACTURED LOT). THE THV DELIVERY SYSTEM BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST DUE TO CONTACT WITH A HIGHLY CALCIFIED ANNULUS. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE NATIVE ANNULAR CALCIFICATION AT FULL INFLATION/DEPLOYMENT. IN THIS CASE, PATIENT FACTORS (STJ CALCIFICATION, SEVERE NATIVE VALVE CALCIFICATION, AND MODERATE ROOT CALCIFICATION) LIKELY CONTRIBUTED TO THIS EVENT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2014-01714.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL TAVR PROCEDURE, THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS ADVANCED ACROSS THE NATIVE ANNULUS WITH SOME DIFFICULTY, DUE TO CALCIFICATION ON THE STJ, AND THE BAV WAS PERFORMED. FOLLOWING BAV, A 29MM SAPIEN XT VALVE WAS POSITIONED 50:50 AORTIC/VENTRICULAR. FULL VOLUME WAS USED IN THE NOVAFLEX + DELIVERY SYSTEM (DS) BALLOON. IMMEDIATELY UPON FULL INFLATION, THE DS BALLOON RUPTURED. THE FINAL POSITION OF THE VALVE WAS 60:40 A/V, RESULTING IN 1-2+ AORTIC INSUFFICIENCY (AI). IT WAS DETERMINED THAT DUE TO THE DS BALLOON RUPTURE, THE VALVE WAS NOT INFLATED AND HELD FOR 3 SECONDS. A SECOND DS WAS PREPARED WITH 33ML AND POST DILATION WAS PERFORMED. THE SECOND DS BALLOON ALSO RUPTURED WHEN FULLY INFLATED. IT WAS DETERMINED THAT THE SECOND BALLOON WAS FULLY INFLATED FOR A SLIGHTLY LONGER DURATION, RESULTING IN NO PARAVALVULAR LEAK OR CENTRAL AI. THE PROCEDURE WAS COMPLETED THE PATIENT WAS EXTUBATED AND TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT¿S NATIVE ANNULUS MEASURED 24.6X27.6MM (VALVE AREA OF 524MM2) BY CT. SEVERE NATIVE VALVE CALCIFICATION AND MODERATE ROOT CALCIFICATION WERE NOTED. THE STJ DIAMETER WAS MEASURED AS 35MM WITH CALCIFICATION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441345 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 59646636

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention