BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 26MM

    MDR report key: 3250582 · Received July 26, 2013

    Report

    Report Number
    2015691-2013-20688
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. 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 THE EXACT CAUSE OF THE EVENT CANNOT BE CONFIRMED HOWEVER, PER REPORT; IT WAS NOTICED THAT CALCIFICATION ON THE STJ CAUSED THE BALLOON BURST. 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

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE, THE DELIVERY BALLOON BURST UPON DEPLOYMENT OF THE 26MM SAPIEN VALVE. THE MEDICAL TEAM PREPPED A TYSHAK BALLOON FOR POST DILATION, AND THIS BALLOON ALSO BURST UPON INFLATION. IT WAS NOTED THAT CALCIUM ON THE SINOTUBULAR JUNCTION (STJ) WAS THE CAUSE OF THE BALLOON RUPTURE. A SECOND DELIVERY SYSTEM WAS POSITIONED MORE VENTRICULAR AND INFLATED SUCCESSFULLY FOR POST DILATION. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350037 RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26 59348388

    Patients

    Seq Age Sex Outcome Treatment
    1 91