BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA 3 DELIVERY SYSTEM

    MDR report key: 3811346 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01138
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, PER REPORT, THE BALLOON WAS BELIEVED TO HAVE BURST WHEN IT MADE CONTACT WITH THE PATIENT¿S RIGHT LOOSE AND PRE-EXISTING OSTEOSTENT DURING THE PERIOD OF INFLATION. 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 TRANSAPICAL TAVR PROCEDURE, THE BALLOON ON THE ASCENDRA 3 DELIVERY SYSTEM RUPTURED WHILE THE VALVE WAS CLOSE TO BEING FULLY DEPLOYED. PER REPORT, THE VALVE WAS DEPLOYED IN A 50:50 POSITION, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). THE DELIVERY DEVICE WAS REMOVED AND THE VALVE WAS POST DILATED WITH A 25X4 ZMED BAV BALLOON. A REPEAT ECHOCARDIOGRAM SHOWED THE PVL HAD REDUCED TO MILD. THE PATIENT WAS IN STABLE CONDITION AT THE END OF THE PROCEDURE. THE BALLOON BURST WAS ATTRIBUTED TO THE CONTACT THAT WAS MADE BETWEEN THE BALLOON AND A PRE-EXISTING STENT IN THE PATIENT'S RIGHT CORONARY ARTERY DURING INFLATION. PER REPORT, THE PATIENT¿S AORTIC VALVE WAS SEVERELY CALCIFIED, THE AORTIC ROOT WAS SEVERELY CALCIFIED, AND THERE WAS MILD MITRAL ANNULAR CALCIFICATION (MAC) AND NO VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT¿S EJECTION FRACTION WAS 59%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291182 ASCENDRA 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120AS26 59647541

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR