BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10394009 · Received August 11, 2020

    Report

    Report Number
    2015691-2020-13035
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 17, 2020
    Report Date
    July 17, 2020
    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 · 0

    ADDITIONAL INFORMATION WAS RECEIVED. SECTIONS B5 WAS CORRECTED. THE SAPIEN 3 VALVE AND STENT WAS NOT DEPLOYED IN THE RPA AND A STENT WAS NOT DEPLOYED OVER THE VALVE. THE DEVICES WERE NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. NO IMAGERY WAS PROVIDED. DHR REVIEW AND LOT HISTORY REVIEW WERE UNABLE TO BE PERFORMED AS WORK ORDER WAS NOT PROVIDED. THE IFU, AND DEVICE PREPARATION TRAINING MANUALS WERE REVIEWED FOR INSTRUCTIONS/GUIDANCE FOR PREPARATION AND USE OF THE DEVICES. HOWEVER, THIS WAS A PULMONIC CASE AND THE SAPIEN 3 ULTRA THV (S3U) WITH THE COMMANDER DELIVERY SYSTEM (DS) IS CURRENTLY INDICATED FOR NATIVE AORTIC VALVE, AND SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE REPLACEMENT. THE IFU AND TRAINING MANUALS IN THIS SECTION ARE FOR A TF PROCEDURE IN THE AORTIC POSITION FOR RELEVANT GUIDANCE FOR AN S3U IMPLANT USING A COMMANDER DS. PER THE PROCEDURAL TRAINING MANUAL, THV DEPLOYMENT: THV RETRIEVAL BACK INTO SHEATH TIP: THV CAN BE RETRIEVED THROUGH SHEATH ONLY BEFORE THV DEPLOYMENT (STILL CRIMPED). ENSURE THE THV IS CENTERED ON THE FLEX TIP. ENSURE DELIVERY SYSTEM IS LOCKED. VERIFY THE FLEX CATHETER IS COMPLETELY UNFLEXED. RETRACT THE THV AND DELIVERY SYSTEM INTO THE SHEATH ENSURING THE THV IS COMPLETELY INSIDE THE SHEATH AND JUST PAST THE SHEATH TIP. ENSURE THE EDWARDS LOGO ON THE SHEATH HANDLE IS FACING UPWARD. WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT RE-USE THE SHEATH, THV OR DELIVERY SYSTEM ONCE THV IS RETRIEVED. NOTE: CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE. NOTE: DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THV PAST THE SHEATH TIP AND ENSURE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN. NOTE: RETRIEVABILITY IS BASED ON PRECLINICAL TESTING. BALLOON BURST: IF 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. BALLOON BURST: STEP-BY-STEP: 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. NO IFU/ TRAINING DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING OF THE DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. 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. THE COMPLAINT WAS UNABLE TO BE CONFIRMED AS NO DEVICE OR RELEVANT IMAGERY WAS PROVIDED FOR EVALUATION. DUE TO NO DEVICE BEING RETURNED FOR EVALUATION, NO VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS WAS ABLE TO BE PERFORMED. IN ADDITION, DEVICE LOT INFORMATION WAS NOT PROVIDED, SO DEVICE HISTORY AND LOT HISTORY RECORDS WERE UNABLE TO BE REVIEWED. AS SUCH, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. REVIEW OF MANUFACTURING MITIGATIONS PROVIDED NO INDICATION THAT A MANUFACTURING NONCONFORMANCE WAS A CONTRIBUTING FACTOR. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE REPORT, DURING DEPLOYMENT A 23MM SAPIEN 3 ULTRA VALVE IN THE PULMONIC POSITION USING A 23MM COMMANDER DELIVERY SYSTEM AND 26FR NON-EDWARDS SHEATH, THE DELIVERY SYSTEM BALLOON BURST. THE BALLOON BURST WAS CONSIDERED TO BE POSSIBLY DUE TO INTERACTION WITH THE PRE-STENT THAT WAS PLACED IN THE RPA. ADDITIONALLY, THE STENT THAT WAS CRIMPED ON THE SAPIEN 3 VALVE MAY HAVE CAUSED THE BALLOON BURST UPON INFLATION. WHILE THE BALLOONS ARE SUFFICIENTLY DESIGNED AND TESTED FOR RATED BURST PRESSURES WELL ABOVE THEIR INFLATION PRESSURE, INTERACTION WITH THE STENT/PRE-STENT CAN PUNCTURE THE BALLOON LEADING TO BURST BALLOON. ALTHOUGH A DEFINITE ROOT CAUSE IN UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (INTERACTION WITH STENT/ PRE-STENT) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. SUBSEQUENTLY, IT WAS REPORTED THE VALVE COULD NOT BE REMOVED THROUGH THE NON-EDWARDS SHEATH, IT WAS GETTING STUCK AT THE SHEATH DISTAL TIP. A NON-EDWARDS STENT WAS CRIMPED ON THE SAPIEN 3 VALVE, WHICH ADDED TO THE PROFILE OF THE VALVE. THE BURST BALLOON ALTERED THE BALLOON PROFILE LEADING TO A LARGER DIAMETER BALLOON MOVING THROUGH THE SHEATH TIP. THE LARGER DIAMETER WOULD LEAD TO INCREASE IN RESISTANCE AS THE DEVICE BALLOON IS SUSCEPTIBLE TO CATCHING ON THE SHEATH TIP. SIMILARLY, A STENT CRIMPED ON TOP OF S3U VALVE WOULD ALSO INCREASE THE OVERALL PROFILE, LEADING TO WITHDRAWAL DIFFICULTY. PER TRAINING MANUAL, ¿DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THV PAST THE SHEATH TIP AND ENSURE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN.¿ THIS RETRIEVAL METHOD IS ONLY TESTED ON EDWARDS ESHEATH. THE NON-EDWARDS SHEATH MAY NOT BE COMPATIBLE FOR REMOVAL OF DELIVERY SYSTEM WITH THE CRIMPED VALVE. THE INCOMPATIBILITY CAN POSSIBLY LEAD TO THE WITHDRAWAL DIFFICULTY AS REPORTED. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (RETRIEVAL OF CRIMPED VALVE WITH BALLOON BURST/STENT CRIMPED ON TOP OF VALVE THROUGH A NON-EDWARDS SHEATH) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE COMPLAINT FOR ¿BALLOON ¿ BURST¿ WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING EVALUATION. A DEFINITE ROOT CAUSE WAS UNABLE TO BE DETERMINE. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (INTERACTION WITH STENT/PRE-STENT) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME. THE COMPLAINT FOR ¿DELIVERY SYSTEM ¿ WITHDRAWAL DIFFICULTY ¿ THROUGH SHEATH¿ WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NONCONFORMANCES WERE IDENTIFIED DURING EVALUATION. A DEFINITE ROOT CAUSE WAS UNABLE TO BE DETERMINE. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (RETRIEVAL OF CRIMPED VALVE WITH BALLOON BURST/STENT CRIMPED ON TOP OF VALVE THROUGH A NON-EDWARDS SHEATH) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Description of Event or Problem · 0

    DURING DEPLOYMENT A 23MM SAPIEN 3 ULTRA VALVE IN THE PULMONIC POSITION USING A 23MM COMMANDER DELIVERY SYSTEM AND 26FR NON-EDWARDS SHEATH, THE DELIVERY SYSTEM BALLOON BURST. THE VALVE DID NOT OPEN DURING DEPLOYMENT. THE VALVE COULD NOT BE REMOVED THROUGH THE NON-EDWARDS SHEATH, IT WAS GETTING STUCK AT THE SHEATH DISTAL TIP. A NON-EDWARDS STENT WAS CRIMPED ON THE SAPIEN 3 VALVE, WHICH ADDED TO THE PROFILE OF THE VALVE. THE PATIENT WAS CONVERTED TO OPEN SURGERY. THE NON-EDWARDS SHEATH, COMMANDER DELIVERY SYSTEM AND VALVE HAD TO BE SURGICALLY REMOVED. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. THE BALLOON BURST WAS CONSIDERED TO BE POSSIBLY DUE TO INTERACTION WITH THE PRE-STENT THAT WAS PLACED IN THE RPA. ADDITIONALLY, THE STENT THAT WAS CRIMPED ON THE SAPIEN 3 VALVE MAY HAVE CAUSED THE BALLOON BURST UPON INFLATION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING DEPLOYMENT A 23MM SAPIEN 3 ULTRA VALVE IN THE PULMONIC POSITION USING A 23MM COMMANDER DELIVERY SYSTEM AND 26FR NON-EDWARDS SHEATH, THE DELIVERY SYSTEM BALLOON BURST. THE VALVE DID NOT OPEN DURING DEPLOYMENT. THE VALVE COULD NOT BE REMOVED THROUGH THE NON-EDWARDS SHEATH, IT WAS GETTING STUCK AT THE SHEATH DISTAL TIP. A NON-EDWARDS STENT WAS CRIMPED ON THE SAPIEN 3 VALVE, WHICH ADDED TO THE PROFILE OF THE VALVE. THE SAPIEN 3 VALVE AND STENT WAS DEPLOYED IN THE RPA AND A STENT WAS DEPLOYED OVER THE VALVE. THE PATIENT WAS CONVERTED TO OPEN SURGERY. THE NON-EDWARDS SHEATH AND COMMANDER DELIVERY SYSTEM HAD TO BE SURGICALLY REMOVED. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. THE BALLOON BURST WAS CONSIDERED TO BE POSSIBLY DUE TO INTERACTION WITH THE PRE-STENT THAT WAS PLACED IN THE RPA. ADDITIONALLY, THE STENT THAT WAS CRIMPED ON THE SAPIEN 3 VALVE MAY HAVE CAUSED THE BALLOON BURST UPON INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853456 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention