BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 11620779 · Received April 6, 2021

    Report

    Report Number
    2015691-2021-02294
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 19, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103193961
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-02302. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. IN ADDITION, NO RELEVANT IMAGERY WAS PROVIDED FOR REVIEW. DUE TO THE UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. THEREFORE, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED DURING THE EVALUATION. THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS. ALL INSPECTIONS PASSED SPECIFICATIONS FOR LOT RELEASE. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCES CONTRIBUTED TO THE REPORTED EVENTS. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO ADDITIONAL SIMILAR COMPLAINTS RELATING TO BALLOON BURST. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. PER INSTRUCTION FOR USE (IFU) FOR DELIVERY SYSTEM BALLOON BURSTS OR LEAKS DURING DEPLOYMENT WITHOUT THV EMBOLIZATION: DO NOT USE EXCESSIVE FORCE. TAKE CARE WHEN CROSSING THE THV, TRACKING BACK OVER THE ARCH AND REMOVING THE DELIVERY SYSTEM (THROUGH THE TIP OF THE SHEATH). MAINTAIN GUIDEWIRE POSITION. CHECK FOR PV LEAKS UNDER ECHO. IF POST-DILATION NEEDED, USE A NEW DELIVERY SYSTEM AND SHEATH. TAKE CARE WHEN CROSSING THE DEPLOYED VALVE TO PREVENT POTENTIAL EMBOLIZATION. IF A BALLOON BURST IS SUSPECTED, DO NOT ATTEMPT TO PULL BACK THE DELIVERY SYSTEM INTO THE SHEATH UNTIL YOU ARE PREPARED TO CONDUCT THE FOLLOWING STEPS: ATTEMPT TO VISUALIZE LOCATION OF TEAR EITHER IN TEE OR VIA ANGIO THROUGH THE PIGTAIL OR CATHETER/DELIVERY SYSTEM. WHEN REMOVING, ENSURE THE CATHETER/DELIVERY SYSTEM AND WIRE ARE COAXIAL WITH THE SHEATH TIP. WATCH UNDER FLUORO WITH EVERY MOVEMENT. BE PATIENT AND PULL GENTLY ESPECIALLY NEAR TEAR AND BALLOON SHOULDER TRANSITIONS. DO NOT FORCE IF RESISTANCE IS MET NEAR OR AT THE SHEATH TIP. FORCE COULD RESULT IN ADDITIONAL TEARING OF THE BALLOON MATERIAL AND THE BALLOON MATERIAL OR TIP COMING OFF. IF SUCCESSFUL IN PULLING THE ENTIRE BALLOON AND DELIVERY SYSTEM TIP INTO THE TIP OF THE SHEATH, WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT ATTEMPT TO PULL THE DELIVERY SYSTEM THROUGH THE REMAINING LENGTH OF THE SHEATH. IF UNABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, DO NOT ATTEMPT TO REMOVE THE EXPOSED BALLOON THROUGH THE ENTIRE PERIPHERAL VASCULATURE, AS THERE IS RISK OF MAJOR COMPLICATIONS. CONVERSION TO SURGERY IS RECOMMENDED TO REMOVE THE SYSTEM AND A SURGEON SHOULD BE IN A POSITION TO BE ABLE TO EVALUATE THE SITUATION. BASED ON A MEDICAL ASSESSMENT OF THE SIZE, TORTUOSITY, AND EXTENT OF CALCIFICATION OF THE PERIPHERAL VESSELS, EVALUATE THE RISKS AND TRADEOFFS OF CAREFULLY WITHDRAWING THE SYSTEM INTO A MORE PERIPHERAL ANATOMY IN ORDER TO ALLOW A MORE LOCALIZED SURGICAL PROCEDURE. CONSIDER USE OF AN OCCLUSION BALLOON TO MITIGATE BLEEDING RISKS, ESPECIALLY IF THERE IS RESISTANCE ENCOUNTERED DURING WITHDRAWAL. IF RESISTANCE IS UNACCEPTABLY HIGH, CONVERT TO SURGERY RATHER THAN USING EXCESSIVE FORCE TO PULL THE SHEATH/DELIVERY SYSTEM TO A DIFFERENT POSITION. ENSURE THE VALVE IS WELL OPPOSED. IF IT IS NOT, YOU MUST POST DILATE IMMEDIATELY WITH ANOTHER BALLOON OR DELIVERY SYSTEM AND SHEATH. TAKE CARE WHEN CROSSING THE DEPLOYED VALVE TO PREVENT POTENTIAL EMBOLIZATION. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND 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 COMPLAINT FOR BALLOON BURST WAS UNABLE TO BE CONFIRMED AS NEITHER IMAGERY NOR THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF LOT HISTORY, DHR AND MANUFACTURING NON-CONFORMANCE DID NOT INDICATE A POTENTIAL MANUFACTURING NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. AS REPORTED, '29MM VALVE WAS SUCCESSFUL IN DEPLOYING THE VALVE HOWEVER DURING DEPLOYMENT THE DELIVERY BALLOON RUPTURED'. IN THIS CASE, THE PATIENT HAD A VALVE IN VALVE IN THE MITRAL POSITION. A PRE- EXISTING VALVE WAS PRESENT IN THE PATIENT LANDING ZONE. IT IS POSSIBLE THAT THE INTERACTION BETWEEN THE BALLOON WITH AN EXISTING VALVE MAY COMPROMISE THE BALLOON WALL DURING INFLATION THAT SUBSEQUENTLY LED TO A BURST BALLOON. A DEFINITE ROOT CAUSE WAS UNABLE TO BE DETERMINED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (PRE EXISTING VALVE) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, THE REPORTED UNSPECIFIED VASCULAR PROBLEM WAS LIKELY CAUSED BY DEVICE MANIPULATION DURING WITHDRAWAL OF THE DEVICES AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT (ACCESS VESSELS WITH TORTUOSITY). SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE/PREVENTIVE ACTIONS AND NO PRODUCT RISK ASSESSMENT ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. THIS IS 1 OF 2 MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TRANSSEPTAL TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE WITH A 29MM SAPIEN 3 ULTRA VALVE IN A PREVIOUSLY IMPLANTED SURGICAL VALVE, THE DELIVERY SYSTEM BALLOON RUPTURED DURING VALVE DEPLOYMENT. THE VALVE WAS IMPLANTED SUCCESSFULLY. UPON REMOVAL OF THE DELIVERY SYSTEM, DAMAGE TO THE TIP OF THE SHEATH AND SHEATH LINER TORN WAS NOTED. 'THERE WAS VENOUS BLEEDING NOTED AND WAS REPAIRED WITH A STITCH'. THE PATIENT IS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521857 EDWARDS COMMANDER DELIVERY SYSTEM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600LDS29A 63474693 00690103193961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention