COMMANDER DS WITH SAPIEN 3
Report
- Report Number
- 2015691-2021-02163
- Event Type
- Injury
- Date Received
- March 30, 2021
- Date of Event
- March 3, 2021
- Report Date
- May 21, 2021
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICES WERE NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THEREFORE, NO VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL TESTING COULD BE PERFORMED. 3MENSIO WAS PROVIDED FROM SITE AND IT WAS OBSERVED THE ILLIAC HAD CALCIFICATION AND THE PATIENTS ACCESS VESSEL HAD CALCIFICATION AND TORTUOSITY. DHR AND LOT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE WAS UNAVAILABLE. THE IFU, DEVICE PREPARATION TRAINING MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS/GUIDANCE FOR PREPARATION AND USE OF THE DEVICES. PER THE PROCEDURAL TRAINING MANUAL, THV DEPLOYMENT: CHECK TO ENSURE: THV IS EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS. FLEX TIP IS ON THE TRIPLE MARKER. BALLOON LOCK IS LOCKED. PERFORM THV DEPLOYMENT: UNLOCK THE INFLATION DEVICE. INITIATE RAPID PACING ENSURING 1:1 CAPTURE, SBP LESS THAN 50 MMHG, AND PULSE PRESSURE LESS THAN 10 MMHG. CONFIRM PLACEMENT OF CENTER MARKER WITHIN OPTIMAL INITIAL CENTER MARKER ZONE. BEGIN INITIAL DEPLOYMENT WITH A SLOW CONTROLLED INFLATION. FULLY INFLATE AND HOLD FOR 3 SECONDS TO ENSURE COMPLETE DEPLOYMENT. COMPLETELY DEFLATE THE BALLOON. STOP PACING AND WITHDRAW THE BALLOON FROM THE NATIVE VALVE. ADDITIONAL CONSIDERATIONS: VERIFY FLEX TIP IS ON TRIPLE MARKER TO ENSURE FULL INFLATION OF BALLOON DURING DEPLOYMENT. ENSURE STABILITY OF DELIVERY SYSTEM DURING THV DEPLOYMENT. SLOW INFLATION DURING INITIAL DEPLOYMENT MAY HELP WITH STABILITY OF THE DELIVERY SYSTEM AND THV DURING DEPLOYMENT. IF CONSIDERED, REPOSITION ONLY AT THE VERY EARLY STAGE OF DEPLOYMENT. DO NOT EXCEED 20 SECONDS FOR INFLATION AND DEFLATION OF THE DELIVERY SYSTEM. ALWAYS MAINTAIN CONTROL OF THE PLUNGER OF INFLATION DEVICE WHEN RELEASING IT. NEVER LOCK THE INFLATION DEVICE DURING BAV OR THV DEPLOYMENT. DELIVERY SYSTEM REMOVAL: COMPLETELY UNFLEX THE DELIVERY SYSTEM. ENSURE FLEX TIP IS STILL OVER THE TRIPLE MARKER. ENSURE BALLOON LOCK IS LOCKED. ENSURE THE BALLOON IS COMPLETELY DEFLATED. RETRACT LOADER (IF NEEDED). PULL THE ENTIRE DELIVERY SYSTEM THROUGH THE SHEATH. SHEATH REMOVAL: REMOVE THE SUTURE SECURING THE SHEATH. REMOVE THE SHEATH ENTIRELY WITHOUT TORQUEING ENSURING THE EDWARDS LOGO IS FACING UPWARDS. DO NOT READVANCE THE SHEATH AT ANY TIME. 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 COMPLAINTS WERE UNABLE TO BE CONFIRMED AS NO IMAGERY OR THE DEVICE WERE RETURNED FOR EVALUATION. ADDITIONALLY, SINCE THE DEVICE WAS NOT RETURNED, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS, AND THEREFORE NO MANUFACTURING NONCONFORMANCES WERE ABLE TO BE IDENTIFIED. A REVIEW OF MANUFACTURING MITIGATION'S DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NONCONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. PER THE REPORT, DURING REMOVAL OF THE COMMANDER AND ESHEATH THERE WAS RESISTANCE MET WHEN TRYING TO PULL THE COMMANDER INTO THE ESHEATH. THE BALLOON BURST LIKELY ALTERED THE BALLOON PROFILE. THE ALTERED DELIVERY SYSTEM MADE THE DEVICE MORE SUSCEPTIBLE TO BE CAUGHT ON THE SHEATH TIP, WHICH SUBSEQUENTLY RESULTED IN WITHDRAW DIFFICULTY INTO THE SHEATH. AVAILABLE INFORMATION SUGGESTS PROCEDURAL FACTORS (WITHDRAWAL OF BURST BALLOON) COULD HAVE CONTRIBUTED TO THE DIFFICULTY OR INABILITY TO WITHDRAW SYSTEM THROUGH SHEATH EVENT. PER THE REPORT, THE PATIENT HAD CALCIFICATION AND TORTUOSITY PRESENT. 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. ADDITIONALLY, PER THE REPORT, THE PUSHER WAS NOT PULLED BACK PRIOR TO DEPLOYMENT AND CAUSED THE BALLOON TO EXPAND INTO THE PUSHER. PER THE TRAINING MANUAL, VERIFY FLEX TIP IS ON TRIPLE MARKER TO ENSURE FULL INFLATION OF BALLOON DURING DEPLOYMENT. IF THE FLEX TIP IS OVER THE INFLATION BALLOON DURING THV DEPLOYMENT, THE BALLOON WILL NOT INFLATE PROPERLY, POTENTIALLY LEADING TO THE BURST. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) AND PROCEDURAL FACTORS (FLEX TIP NOT RETRACTED DURING DEPLOYMENT) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON BURST EVENT. THE COMPLAINTS WERE UNABLE TO BE CONFIRMED DUE TO LACK OF RELEVANT IMAGERY OR A RETURNED DEVICE. NO MANUFACTURING NONCONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (WITHDRAWAL OF BURST BALLOON) MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY OR INABILITY TO WITHDRAW SYSTEM THROUGH SHEATH EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) AND PROCEDURAL FACTORS (FLEX TIP NOT RETRACTED DURING DEPLOYMENT) MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON BURST EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. SINCE NO LABELING OR IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE AND PREVENTATIVE ACTIONS NOR RISK ASSESSMENT IS REQUIRED AT THIS TIME. 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.
THE INVESTIGATION IS ONGOING.
DURING IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE PUSHER WAS NOT PULLED BACK PRIOR TO DEPLOYMENT AND CAUSED THE BALLOON TO EXPAND INTO THE PUSHER. THE BALLOON BURST DURING DEPLOYMENT. THE VALVE WAS SUCCESSFULLY DEPLOYED. AFTER VALVE DEPLOYMENT, THE BALLOON COULD NOT BE PULLED BACK INTO THE SHEATH TO REMOVE. COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM UPON REENTRY INTO THE DISTAL END OF THE SHEATH COULD NOT BE ACHIEVED. THE TIP OF THE ESHEATH WAS DAMAGED WHILE ATTEMPTING TO PULL THE BALLOON INTO THE ESHEATH. A VASCULAR SURGEON PERFORMED A CUT DOWN TO REMOVE THE DELIVERY SYSTEM AND SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486865 | COMMANDER DS WITH SAPIEN 3 | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750CM26A | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |