EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
Report
- Report Number
- 2015691-2020-13925
- Event Type
- Death
- Date Received
- October 9, 2020
- Date of Event
- September 15, 2020
- Report Date
- September 15, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED. VALVE ALIGNMENT WAS ATTEMPTED IN A STRAIGHT SECTION OF THE ANATOMY. VALVE ALIGNMENT AND/OR FLEX TIP RETRACTION WAS ATTEMPTED MULTIPLE TIMES TO CORRECT ISSUE. THERE WAS A LOT OF TENSION EXPERIENCED, THE SYSTEM WAS NOT TORQUED OR HEAVILY MANIPULATED. THE PATIENT¿S MINIMUM LUMINAL DIAMETER WAS 5.5, HAD A HIGH DEGREE OF CALCIFICATION, AND WAS NOT PARTICULAR TORTUOUS.
A PROCEDURAL PHOTO WAS PROVIDED FOR REVIEW AND THE VALVE WAS OBSERVED OFFSET PROXIMALLY FROM THE DISTAL MARKER WHILE POSITIONED IN THE ANNULUS. THE FLEX TIP HAD BEEN RETRACTED TO THE TRIPLE MARKERS. THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DURING VISUAL ANALYSIS IT WAS OBSERVED THE VALVE WAS CRIMPED AND ALIGNED ON THE INFLATION BALLOON, THE DISTAL BALLOON WAS BUNCHED, AND THE CRIMP BALLOON WAS TORN PROXIMAL TO THE I/C BOND. NO ABNORMALITIES WERE OBSERVED ON THE VALVE. DURING DIMENSIONAL INSPECTION, THE CRIMP BALLOON WALL THICKNESS WAS MEASURED AND WAS FOUND TO MEET SPECIFICATION. DURING FUNCTIONAL TESTING, THE DELIVERY SYSTEM WAS ABLE TO PULL TO THE VALVE ALIGNMENT MARKER AND USE THE FULL FINE ADJUST KNOB WITHOUT ISSUE. DHR REVIEW DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER SIMILAR COMPLAINTS. THE IFU, DEVICE PREPARATION TRAINING MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS/GUIDANCE FOR PREPARATION AND USE OF THE DEVICES. PER THE IFU, VALVE DELIVERY: ADVANCE THE DELIVERY SYSTEM UNTIL THE VALVE EXITS THE SHEATH. NOTE: MAINTAIN THE PROPER ORIENTATION OF THE FLEX CATHETER THROUGHOUT THE PROCEDURE. THE DELIVERY SYSTEM ARTICULATES IN A DIRECTION OPPOSITE FROM THE FLUSH PORT. IN A STRAIGHT SECTION OF THE VASCULATURE, INITIATE VALVE ALIGNMENT BY DISENGAGING THE BALLOON LOCK AND PULLING THE BALLOON CATHETER STRAIGHT BACK UNTIL PART OF THE WARNING MARKER IS VISIBLE. DO NOT PULL PAST THE WARNING MARKER. ENGAGE THE BALLOON LOCK. USE THE FINE ADJUSTMENT WHEEL TO POSITION THE VALVE BETWEEN THE VALVE ALIGNMENT MARKERS. CAUTION: DO NOT TURN THE FINE ADJUSTMENT WHEEL IF THE BALLOON LOCK IS NOT ENGAGED. WARNING: DO NOT POSITION THE VALVE PAST THE DISTAL VALVE ALIGNMENT MARKER. THIS WILL PREVENT PROPER VALVE DEPLOYMENT. CAUTION: MAINTAIN GUIDEWIRE POSITION DURING VALVE ALIGNMENT. WARNING: IF VALVE ALIGNMENT IS NOT PERFORMED IN A STRAIGHT SECTION, THERE MAY BE DIFFICULTIES PERFORMING THIS STEP WHICH MAY LEAD TO DELIVERY SYSTEM DAMAGE AND INABILITY TO INFLATE THE BALLOON. UTILIZING ALTERNATE FLUOROSCOPIC VIEWS MAY HELP WITH ASSESSING CURVATURE OF THE ANATOMY. IF EXCESSIVE TENSION IS EXPERIENCED DURING VALVE ALIGNMENT, REPOSITIONING THE DELIVERY SYSTEM TO A DIFFERENT STRAIGHT SECTION OF THE AORTA AND RELIEVING COMPRESSION (OR TENSION) IN THE SYSTEM WILL BE NECESSARY. DISENGAGE THE BALLOON LOCK AND RETRACT THE TIP OF THE FLEX CATHETER TO THE CENTER OF THE TRIPLE MARKER. ENGAGE THE BALLOON LOCK. POSITION THE THV WITH RESPECT TO THE NATIVE VALVE. AS NECESSARY, UTILIZE THE FLEX WHEEL TO ADJUST THE CO-AXIALITY OF THE THV AND THE FINE ADJUSTMENT WHEEL TO ADJUST THE POSITION OF THE THV. BEFORE DEPLOYMENT, ENSURE THAT THE THV IS CORRECTLY POSITIONED BETWEEN THE VALVE ALIGNMENT MARKERS AND THE FLEX CATHETER TIP IS OVER THE TRIPLE MARKER. BEGIN THV DEPLOYMENT. UNLOCK THE INFLATION DEVICE. ENSURE HEMODYNAMIC STABILITY IS ESTABLISHED AND BEGIN RAPID PACING; ONCE ARTERIAL BLOOD PRESSURE HAS DECREASED TO 50 MMHG OR BELOW, BALLOON INFLATION CAN COMMENCE. USING SLOW CONTROLLED INFLATION, DEPLOY THE THV WITH THE ENTIRE VOLUME IN THE INFLATION DEVICE, HOLD FOR 3 SECONDS AND CONFIRM THAT THE BARREL OF THE INFLATION DEVICE IS EMPTY TO ENSURE COMPLETE INFLATION OF THE BALLOON. DEFLATE THE BALLOON. WHEN THE BALLOON CATHETER HAS BEEN COMPLETELY DEFLATED TURN OFF THE PACEMAKER. PER THE PROCEDURAL TRAINING MANUAL, VALVE ALIGNMENT: UNLOCK, PULL THE BALLOON CATHETER STRAIGHT BACK AT THE Y-CONNECTOR UNTIL PART OF THE WARNING MARKER IS VISIBLE AND LOCK. DO NOT BEND OR APPLY TORQUE TO THE PROXIMAL END OF THE BALLOON CATHETER THROUGHOUT THE PROCEDURE. ROTATE THE BALLOON LOCK AWAY FROM YOU TO LOCK AND TOWARDS YOU TO UNLOCK. LOCK/UNLOCK SYMBOLS ARE FOUND ON THE BALLOON LOCK. CHECK DELIVERY SYSTEM BEFORE VALVE ALIGNMENT. SLOWLY ROTATE THE FINE ADJUSTMENT WHEEL TOWARDS YOU TO CENTER THE THV EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS WITH NO GAP OR OVERLAP. FINE ADJUSTMENT INDICATOR SHOWS HOW MUCH FINE ADJUSTMENT IS LEFT. IF ADDITIONAL FINE ADJUSTMENT IS NEEDED, UNLOCK AND ROTATE THE FINE ADJUSTMENT WHEEL AWAY FROM YOU UNTIL PART OF THE WARNING MARKER IS VISIBLE AND RELOCK. ADDITIONAL CONSIDERATIONS: COMPRESSION MAY BE OBSERVED IN THE DISTAL PORTION OF THE FLEX CATHETER DURING VALVE ALIGNMENT. DIVING MAY BE OBSERVED BETWEEN THE THV AND THE FLEX CATHETER TIP DURING VALVE ALIGNMENT. TO CORRECT: MOVE TO A DIFFERENT STRAIGHT SECTION OF THE AORTA (FOR DIVING ONLY). IF USING THE BALLOON CATHETER, PUSH FORWARD SLIGHTLY, AND THEN CONTINUE PULLING BACK UNTIL PART OF WARNING MARKER IS VISIBLE. IF USING THE FINE ADJUSTMENT WHEEL, REVERSE AND THEN CONTINUE WITH FINE ADJUSTMENT UNTIL THV IS CENTERED EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS. WARNING: IF VALVE ALIGNMENT IS NOT PERFORMED IN A STRAIGHT SECTION, THERE MAY BE DIFFICULTIES PERFORMING THIS STEP WHICH MAY LEAD TO DELIVERY SYSTEM DAMAGE AND INABILITY TO INFLATE THE BALLOON. UTILIZING ALTERNATE FLUOROSCOPIC VIEWS MAY HELP WITH ASSESSING CURVATURE OF THE ANATOMY. IF EXCESSIVE TENSION IS EXPERIENCED DURING VALVE ALIGNMENT, REPOSITIONING THE DELIVERY SYSTEM TO A DIFFERENT STRAIGHT SECTION OF THE AORTA AND RELIEVING COMPRESSION (OR TENSION) IN THE SYSTEM WILL BE NECESSARY. 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 FOR ¿BALLOON TORN¿ AND ¿DELIVERY SYSTEM VALVE MOVEMENT ON BALLOON¿ WERE CONFIRMED BASED ON VISUAL INSPECTION OF RETURNED DEVICE AND THE PROVIDED IMAGERY. HOWEVER, THE COMPLAINTS FOR ¿HANDLE ¿ FINE ADJUST DIFFICULTY¿ WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED IN THE RETURNED SAMPLE. A REVIEW OF LOT HISTORY, DHR, AND MANUFACTURING MITIGATION'S SUPPORTED THAT A MANUFACTURING NON-CONFORMANCE LIKELY DID NOT CONTRIBUTE TO THE REPORTED EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE REPORT, THERE WAS HIGH RESISTANCE DURING VALVE ALIGNMENT IN A STRAIGHT SECTION AND, AFTER MULTIPLE ATTEMPTS, THE VALVE WAS NOT CENTERED EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS. IT IS POSSIBLE THAT TORTUOSITY MAY HAVE CONTRIBUTED TO THE VALVE ALIGNMENT DIFFICULTIES. ALTHOUGH VALVE ALIGNMENT WAS REPORTEDLY PERFORMED IN A STRAIGHT SECTION OF THE AORTA, IMAGERY AND CHARACTERIZATION OF THE DESCENDING AORTA (WHERE VALVE ALIGNMENT WOULD HAVE BEEN PERFORMED) WAS NOT PROVIDED FOR THE EVALUATION. THEREFORE, IT IS POSSIBLE THAT VALVE ALIGNMENT COULD HAVE BEEN PERFORMED AT A BEND/ANGLE, CONTRIBUTING TO HIGH ALIGNMENT FORCES AND TENSION AS DESCRIBED. PERFORMING VALVE ALIGNMENT IN A TORTUOUS VASCULATURE CAN RESULT IN HIGH ALIGNMENT FORCES REQUIRED TO ALIGN THE VALVE ON THE BALLOON AND INDUCE TENSION IN THE SYSTEM. VALVE DIVING (WHERE THE VALVE BECOMES UNSEATED FROM FLEX TIP AND DIVES INTO FLEX TIP LUMEN) MAY HAVE OCCURRED AS A RESULT OF CONDUCTING VALVE ALIGNMENT IN A TORTUOUS SECTION OF THE AORTA, FURTHER INCREASING TENSION IN THE SYSTEM. TENSION IN THE SYSTEM DURING VALVE ALIGNMENT CAN RESULT IN HIGHER FORCES REQUIRED TO ALIGN THE VALVE ON THE INFLATION BALLOON, CONTRIBUTING TO FINE ADJUST DIFFICULTY. UNDER SIMULATED CONDITIONS (SIMULATED TORTUOUS ANATOMY), A PREVIOUSLY PERFORMED ENGINEERING STUDY WAS ABLE TO RECREATE HIGH VALVE ALIGNMENT FORCES. AVAILABLE INFORMATION SUGGESTS THAT PATIENT (TORTUOSITY) AND/OR PROCEDURAL FACTORS (PERFORMING VALVE ALIGNMENT IN NON-STRAIGHT SECTION OF AORTA) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. POTENTIAL ROOT CAUSES FOR SEPARATION OF THE INFLATION BALLOON TO CRIMP BALLOON BOND HAVE BEEN IDENTIFIED AND DOCUMENTED IN A PRODUCT RISK ASSESSMENT. IF HIGH TENSION IS PRESENT IN THE SYSTEM DURING ALIGNMENT, IT MAY HAVE RESULTED IN INCREASED FORCES BEING APPLIED TO THE BOND AREA. THE BOND AREA BETWEEN THE INFLATION AND CRIMP BALLOON MAY SEPARATE WHEN SUBJECTED TO UNUSUALLY HIGH FORCES. AS PER THE TRAINING MANUAL, ¿IF VALVE ALIGNMENT IS NOT PERFORMED IN A STRAIGHT SECTION, THERE MAY BE DIFFICULTIES PERFORMING THIS STEP WHICH MAY LEAD TO DELIVERY SYSTEM DAMAGE AND INABILITY TO INFLATE THE BALLOON.¿ AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (HIGH ALIGNMENT FORCES) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. THE PROCEDURAL IMAGERY PROVIDED DISPLAYED THE VALVE UNALIGNED BETWEEN THE VALVE ALIGNMENT MARKERS (AFTER FLEX TIP HAD BEEN RETRACTED TO TRIPLE MARKERS) WHILE POSITIONED IN THE ANNULUS. WHEN THE DEVICE IS UNLOCKED TO RETRACT THE FLEX TIP, THE STORED TENSION IN THE SYSTEM IS RELEASED AND CAN CAUSE THE VALVE TO SHIFT PROXIMALLY, RESULTING IN THE REPORTED VALVE MOVEMENT. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (RELEASE OF BUILD-UP TENSION IN SYSTEM) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THE PHYSICIAN CONSIDERED A VENTRICULAR PERFORATION BY THE GUIDE WIRE OCCURRED DURING THE PROCEDURE, RESULTING IN THE PATIENT¿S DEATH. THE COMPLAINT FOR ¿HANDLE FINE ADJUST DIFFICULTY¿ WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (TORTUOSITY) AND/OR PROCEDURAL FACTORS (PERFORMING VALVE ALIGNMENT IN TORTUOUS ANATOMY) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. THE COMPLAINT FOR ¿BALLOON TORN¿ WAS CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (HIGH ALIGNMENT FORCES) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. THE COMPLAINT FOR ¿DELIVERY SYSTEM VALVE MOVEMENT ON BALLOON¿ WAS CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (RELEASE OF BUILD-UP TENSION IN SYSTEM) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRODUCT 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.
REFERENCE RELATED MANUFACTURER REPORT NUMBER: 2015691-2020-13926. ADDITIONAL INFORMATION WAS RECEIVED. PER THE PRE-DECONTAMINATION EVALUATION, THE CRIMP BALLOON IC BOND WAS FOUND TO BE TORN. THEREFORE, A CORRECTION TO F10 (DEVICE CODE) WAS MAKE. CODE 1250 WAS REMOVED AND 4008 WAS ADDED. THE INVESTIGATION IS ONGOING.
UDI NUMBER: (B)(4). THE INVESTIGATION IS ONGOING.
AS REPORTED BY OUR AFFILIATES IN (B)(6), PRIOR TO IMPLANT OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION USING TRANSFEMORAL APPROACH, THE FEMORAL AND ILIAC VESSEL WAS PRE-DILATED DUE TO SMALL DIAMETER AND DISEASE. THERE WAS NO DIFFICULTY INSERTING THE ESHEATH. DURING VALVE ALIGNMENT, THERE WAS HIGH RESISTANCE AND, THE VALVE WAS NOT CENTERED EXACTLY BETWEEN THE VALVE ALIGNMENT MARKERS AFTER MULTIPLE ATTEMPTS. THE NATIVE VALVE WAS ABLE TO BE CROSSED WITHOUT ISSUE. AFTER THE FLEX CATHETER WAS PULLED BACK THE VALVE MOVED PROXIMAL. DUE TO THE PATIENT¿S INSTABILITY, THE VALVE WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, THE VALVE DID NOT OPEN DURING INFLATION DUE TO A BALLOON RUPTURE. THE DELIVERY CATHETER WAS REMOVED WITHOUT RESISTANCE. A NON-EDWARDS VALVE WAS IMPLANTED WITHOUT ISSUE. POST PROCEDURE, THE ILIAC AND FEMORAL VESSEL WAS TREATED WITH A COVERED STENT. ONE DAY POST PROCEDURE, THE PATIENT PASSED AWAY. AUTOPSY WAS NOT PERFORMED, BUT THE PHYSICIAN CONSIDERED A VENTRICULAR PERFORATION BY THE GUIDE WIRE OCCURRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1122885 | EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9610TF26U | 62988211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death| R |