BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 11473310 · Received March 12, 2021

    Report

    Report Number
    2015691-2021-01808
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 16, 2021
    Report Date
    May 18, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE COMMANDER DELIVERY SYSTEM WAS RETURNED AFTER BEING USED IN THE PROCEDURE. VISUAL INSPECTION SHOWED A LONGITUDINAL BALLOON BURST THROUGH THE ENTIRE WORKING LENGTH OF THE BALLOON. THE DELIVERY SYSTEM WAS NOTED TO HAVE A BENT PROXIMAL BALLOON SHAFT LIKELY DUE TO RETURNED PACKAGING. NO PROCEDURAL IMAGERY WAS PROVIDED BY THE SITE. DUE TO THE NATURE OF THE COMPLAINT FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED. DIMENSIONAL ANALYSIS REVEALED THE BALLOON WALL THICKNESS AT ALL MEASURED LOCATIONS WAS WITHIN SPECIFICATION. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED 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, AVAILABLE INFORMATION SUGGESTS THAT THE BALLOON BURST WAS LIKELY CAUSED BY PATIENT FACTORS (SEVERE CALCIFICATION OF THE CORONARY CUSP). A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), DURING DEPLOYMENT OF A 23 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH THE BALLOON BURST. THE VALVE WAS IMPLANTED SUCCESSFULLY. THE DELIVERY SYSTEM WAS WITHDRAWN WITHOUT ISSUE. THERE WERE NO PATIENT INJURIES. THE PATIENT WAS DOING WELL POST PROCEDURE. PER MEDICAL OPINION, THE EVENT WAS LIKELY DUE TO PATIENT FACTORS OF CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371444 COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23U

    Patients

    Seq Age Sex Outcome Treatment
    1