BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 5342329 · Received January 4, 2016

    Report

    Report Number
    2015691-2016-00012
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 14, 2015
    Report Date
    December 14, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    RESULT: KNOWN INHERENT RISK OF PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE COMMANDER DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE DELIVERY SYSTEM WAS RETURNED FULLY INSERTED INTO THE ESHEATH WITH THE INFLATION BALLOON PULLED OVER THE NOSE TIP. VISUAL INSPECTION REVEALED A PROXIMAL TEAR AND SEPARATION ON THE INFLATION BALLOON OF THE DELIVERY SYSTEM. DUE TO THE CONDITION OF THE RETURNED DEVICE, IT COULD NOT BE DETERMINED IF THE BALLOON TORE LONGITUDINALLY OR RADIALLY. IT WAS ALSO OBSERVED THAT A PORTION OF THE BALLOON COULD BE MISSING. FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE CONDITION OF THE RETURNED DEVICE (BALLOON BURST AND SEVERELY WINKLED BALLOON). DURING MANUFACTURING, THE DELIVERY SYSTEM BALLOON UNDERGOES MULTIPLE 100% INSPECTIONS AND VERIFICATIONS. THESE INSPECTIONS SUPPORT THAT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE WAS THE SOURCE OF THE COMPLAINT. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL 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, THE COMPLAINTS OF THE DELIVERY SYSTEM BALLOON BURST AND WITHDRAWAL DIFFICULTIES WERE CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE; HOWEVER, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED IN THE RETURNED SAMPLE. A DEFINITE ROOT CAUSE FOR THE DELIVERY SYSTEM BALLOON BURST CANNOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, PATIENT FACTORS (MODERATE ANNULAR CALCIFICATION, SEVERE NATIVE LEAFLET CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION) LIKELY CONTRIBUTED TO THE BALLOON BURST. THE CONDITION OF THE BURST BALLOON LIKELY CONTRIBUTED TO THE REPORTED WITHDRAWAL DIFFICULTIES. IT IS NOT KNOWN AT WHAT POINT THE BALLOON MATERIAL MAY HAVE SEPARATED ¿ DURING OR AFTER USE; NO NEGATIVE EFFECTS TO THE PATIENT WERE REPORTED. 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 TRANSFEMORAL TAVR PROCEDURE, A COMMANDER DELIVERY SYSTEM (DS) BALLOON RUPTURED AT THE END OF THE VALVE INFLATION. DURING THE PROCEDURE, A 26MM SAPIEN 3 VALVE WAS PREPARED WITH AN ADDITIONAL 2CC OF VOLUME. THE NATIVE VALVE WAS CROSSED AND THE SAPIEN 3 VALVE WAS POSITIONED FOR DEPLOYMENT. AT THE END OF THE VALVE INFLATION, THE COMMANDER DS BALLOON RUPTURED. THE VALVE WAS DETERMINED TO BE PROPERLY POSITIONED AND NO FURTHER ACTIONS WERE REQUIRED. DURING THE WITHDRAWAL OF THE DS, THE DS COULD NOT BE PULLED BACK INTO THE ESHEATH DUE TO THE RUPTURED BALLOON. THE ESHEATH AND DS WERE WITHDRAWN TOGETHER. FOLLOWING THE REMOVAL OF THE ESHEATH, THE END OF THE SHEATH WAS OBSERVED TO BE "MINGLED", LIKELY DUE TO THE EFFORTS TO REMOVE THE DS. NO VASCULAR ACCESS ISSUES OR INJURIES WERE NOTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. MODERATE ANNULAR CALCIFICATION, SEVERE NATIVE LEAFLET CALCIFICATION AND SEVERE AORTIC ROOT CALCIFICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS26 60215151

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention