BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA 3 DELIVERY SYSTEM, 23MM

    MDR report key: 3952738 · Received July 23, 2014

    Report

    Report Number
    2015691-2014-01660
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO. 2015691-2014-01661.

    Additional Manufacturer Narrative · 1

    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. 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 [SHARP AND JAGGED STJ CALCIFICATION] CONTRIBUTED TO THE BALLOON BURSTS. 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 AT THIS TIME.

    Description of Event or Problem · 1

    DURING A TRANSAORTIC TAVR PROCEDURE, TWO DELIVERY SYSTEM BALLOONS RUPTURED, ONE DURING VALVE DEPLOYMENT, THE SECOND DURING POST DILATION OF THE VALVE. INITIALLY, A BAV WAS PERFORMED USING AN EW 20X3MM BAVC. A 23MM SAPIEN VALVE AND ASCENDRA 3 DELIVERY SYSTEM WERE PREPARED AND POSITIONED 50:50 IN THE ANNULUS. DURING DEPLOYMENT OF THE VALVE, IT WAS APPARENT THAT THE DELIVERY BALLOON HAD RUPTURED. THE VALVE WAS ALMOST COMPLETELY EXPANDED, BUT NEEDED TO BE FULLY DEPLOYED. A SECOND 23MM DELIVERY SYSTEM WAS PREPARED AND PLACED 50:50 IN THE ANNULUS. THE DELIVERY BALLOON WAS INFLATED AND JUST AS IT ACHIEVED FULL INFLATION, THE BALLOON RUPTURED IN THE SAME FASHION AS THE FIRST. TEE SHOWED NO PARAVALVULAR LEAK AND TRACE CENTRAL AORTIC INSUFFICIENCY. THE PATIENT WAS STABLE WITH GOOD HEMODYNAMICS. THE CASE WAS ENDED WITH SUCCESSFUL DEPLOYMENT OF THE VALVE AND ACCEPTABLE RESULT. THE CALCIUM IN THE SINOTUBULAR JUNCTION [STJ] APPEARED SHARP AND JAGGED AND WAS REPORTED AS THE LIKELY CAUSE OF BOTH BALLOON RUPTURES. THIS REPORT IS FOR THE FIRST ASCENDRA 3 DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431403 ASCENDRA 3 DELIVERY SYSTEM, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120AS23 59688706

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention