BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS ASCENDRA 3 DELIVERY SYSTEM

    MDR report key: 3905147 · Received July 1, 2014

    Report

    Report Number
    2015691-2014-01492
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION SO THE DEVICE WAS DISCARDED. 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 TECHNICAL SUMMARY. 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, THE EXACT CAUSE OF THE BALLOON BURST IS UNKNOWN, HOWEVER, THE SEVERE AORTIC ROOT CALCIFICATION, SEVERE NATIVE LEAFLET CALCIFICATION, AND THE SMALL (STJ) MOST LIKELY CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    DURING THE TRANSAPICAL TAVR PROCEDURE, THE ASCENDRA DELIVERY SYSTEM BALLOON BURST UPON FULL DEPLOYMENT. THE 23MM VALVE WAS ALMOST FULLY EXPANDED. THERE WAS SOME PARAVALVULAR LEAK (PVL) NOTED. BECAUSE THE PATIENT WAS ON BYPASS, IT WAS NOT CLEAR IF THE PVL WAS A RESULT OF THE BYPASS OR ACTUAL PVL. THE VALVE WAS POST-DILATED AS A PRECAUTION, AND THE PVL WAS REDUCED TO TRACE-MILD. THE DELIVERY SYSTEM WAS ABLE TO BE PULLED THROUGH THE SHEATH. THERE WAS NO SEPARATION OF THE DELIVERY SYSTEM; THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT¿S AORTIC ROOT WAS SEVERELY CALCIFIED, AS WAS THE NATIVE LEAFLETS. THE NATIVE VALVE WAS MODERATELY CALCIFIED. REGARDING THE PERCEIVED ROOT CAUSE OF THE BALLOON BURST, THE SEVERE AORTIC ROOT CALCIFICATION AND THE SMALL SINOTUBULAR JUNCTION (STJ) COULD HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383511 EDWARDS ASCENDRA 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120AS23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention