BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY

    MDR report key: 11675622 · Received April 15, 2021

    Report

    Report Number
    2015691-2021-02475
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103208078
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE 26MM COMMANDER DELIVERY SYSTEM RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION WITH THE INFLATION SYRINGE AT LOCKED POSITION WITH ZERO FLEX AND 75% FINE ADJUST USED. THE DELIVERY SYSTEM WAS VISUALLY INSPECTED. THE INFLATION BALLOON BURST LONGITUDINALLY; NO BALLOON MATERIAL APPEARS TO BE MISSING. THE BALLOON COVER DID NOT RETURN WITH DELIVERY SYSTEM. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO CONDITION OF RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED THROUGH VISUAL INSPECTION. SINGLE WALL THICKNESS OF THE BALLOON AROUND THE BURST WAS TAKEN AS A THIN WALL CAN CONTRIBUTE TO A BURST. ALL MEASUREMENTS TAKEN ALONG THE EDGE OF THE BURST BALLOON MET SPECIFICATION. THE BALLOON BURST COMPLAINT WAS CONFIRMED WITH NO APPLICABLE TECHNICAL SUMMARY AVAILABLE. THE WORK ORDERS RELATED TO THE MANUFACTURING OF THE DEVICES AND COMPONENTS THAT COULD POTENTIALLY CONTRIBUTE TO THE COMPLAINT WERE REVIEWED AND DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW OF THE RELATED WORK ORDER WAS PERFORMED AND REVEALED COMPLAINTS RELATING TO THE BALLOON BURST COMPLAINT CODES. THE EVENT WAS CONFIRMED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM GOES THROUGH MULTIPLE 100% INSPECTIONS. ALL INSPECTIONS ARE CONDUCTED ON 100% OF UNITS, EXCEPT IN THE CASE OF PRODUCT VERIFICATION (PV) TESTING, WHERE THE TESTED UNITS ARE CHOSEN ON A SAMPLING BASIS. A REVIEW OF EDWARDS MANUFACTURING AND ASSEMBLY PROCESS DID NOT REVEAL ANY NON-CONFORMANCE THAT COULD CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, IT IS POSSIBLE THAT A SUPPLIER MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. THE COMMANDER IFU, DEVICE PREPARATION MANUAL, AND DEVICE TRAINING MANUAL WERE REVIEWED. NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. A COMPLAINT HISTORY REVIEW ON CONFIRMED DEVICE COMPLAINTS (RETURNED AND NO PRODUCT RETURNED) FROM APRIL 2020 TO MARCH 2021 FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) WAS PERFORMED WITH THE CODES IDENTIFIED AS RELATED. OF THE ROOT CAUSES IDENTIFIED, PATIENT CALCIFICATION WAS NOTED AS POTENTIALLY APPLICABLE TO THE COMPLAINT EVENT. 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. REGARDING THE BALLOON BURST: AS REPORTED 'AS PER MEDICAL OPINION, SINCE THE NATIVE VALVE WAS HIGHLY CALCIFIED, IT COULD HAVE CAUSED THE BALLOON RUPTURE'. THE PRESENCE OF CALCIFICATION CAN CREATE A CHALLENGING ANATOMY FOR BALLOON INFLATION. WHILE THE BALLOONS ARE SUFFICIENTLY DESIGNED AND TESTED FOR RATED BURST PRESSURES WELL ABOVE THEIR INFLATION PRESSURE, CALCIFIED NODULES CAN COMPROMISE THE STRUCTURE OF THE BALLOON WALL VIA FOLLOWING MECHANISMS SUCH AS PUNCTURE, LOCAL OVERSTRETCHING, OPEN CELL IMPINGEMENT, OR STRESS CONCENTRATION. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON BURST AND THE DIFFICULTY IN BALLOON COVER REMOVAL MAYBE TIED TO THE SCAR. SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED, NO ESCALATION TO A PRODUCT RISK ASSESSMENT WAS REQUIRED. AS NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. THE BALLOON BURST WAS CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING PRODUCT EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING, AS THE DEVICE RETURN AND EVALUATION IS EXPECTED.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), DURING THE 26MM SAPIEN 3 ULTRA CASE BY TF APPROACH IN AORTIC POSITION, WHILE PEELING AWAY THE BALLOON COVER OF THE 26MM COMMANDER DS, THE PLASTIC WAS PARTIALLY DETACHED AND A SCALPEL WAS REQUIRED TO FINISH THE STEP. THE BALLOON WAS THEN DE-AIRED ACCORDING TO THE PROCEDURE MANUAL AND THE AIR RESISTANCE WAS CONFIRMED. NORMAL BUBBLES COMING THROUGH THE BALLOON CATHETER TO THE 60 ML SYRINGE WERE SEEN. WHEN THE BALLOON WAS INFLATED TO IMPLANT THE 26 MM SAPIEN 3 ULTRA, THE BALLOON BURST AT THE MAXIMUM INFLATION POINT. INFLATOR WAS FILLED WITH 22 ML (NOMINAL -1) AND POST DILATION WAS PERFORMED WITH A EDWARDS BAV 26 MM FILLED WITH 21ML CONTRAST. THE SYSTEM WAS REMOVED AS A WHOLE UNIT AND NO DIFFICULTIES WERE ENCOUNTERED WHILE REMOVING THE DS THROUGH THE ESHEATH. THE PATIENT WAS STABLE AND SAFELY DISCHARGED. AS PER MEDICAL OPINION, SINCE THE NATIVE VALVE WAS HIGHLY CALCIFIED, THIS COULD HAVE CAUSED THE BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566729 EDWARDS COMMANDER DELIVERY AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF26U 63407921 00690103208078

    Patients

    Seq Age Sex Outcome Treatment
    1