EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
Report
- Report Number
- 2015691-2020-13958
- Event Type
- Injury
- Date Received
- October 14, 2020
- Date of Event
- September 23, 2020
- Report Date
- September 23, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION: SECTION H6: EVALUATION CODES; SECTION H10: NARRATIVE TEXT. THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. REVIEW OF THE CASE IMAGERY PROVIDED REVEALED A GAP BETWEEN THE VALVE AND DISTAL VALVE ALIGNMENT MARKER. DEVICE HISTORY REVIEW (DHR) REVIEW WAS PERFORMED FOR THE COMPONENTS MOST RELEVANT TO THE REPORTED EVENT. THE WORK ORDERS DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE'S THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT HISTORY REVIEW REVEALED NO OTHER SIMILAR COMPLAINTS. COMPLAINT HISTORY REVIEW FROM OCTOBER 2019 TO SEPTEMBER 2020 FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED OTHER SIMILAR REPORTED EVENTS FOR THE ASSOCIATED COMPLAINT CODES. AVAILABLE INFORMATION SUGGESTS PATIENT FACTORS (VESSEL CALCIFICATION AND TORTUOSITY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. PER INSTRUCTIONS FOR USE (IFU) AND TRAINING MANUALS DURING VALVE ALIGNMENT A GAP BETWEEN THE THV AND DISTAL VALVE ALIGNMENT MARKER MAY RESULT IN DIFFICULTY CROSSING. AN OVERLAP CANNOT BE REVERSED AND MAY PREVENT PROPER THV DEPLOYMENT. NOTE: DO NOT BEND OR APPLY TORQUE TO THE PROXIMAL END OF THE BALLOON CATHETER THROUGHOUT THE PROCEDURE. WARNING: DO NOT POSITION THV PAST THE DISTAL VALVE ALIGNMENT MARKER. THIS WILL PREVENT PROPER THV DEPLOYMENT. 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. NOTE: THV MOVES IN ONLY ONE DIRECTION RELATIVE TO THE BALLOON. PERFORM VALVE ALIGNMENT IN THE STRAIGHT SECTION OF THE AORTA. PER THE IFU AND TRAINING MANUALS WHEN CROSSING NATIVE VALVE ENSURE THE FLEX CATHETER TIP IS FLUSH WITH THE THV FOR SUPPORT DURING CROSSING. BE PATIENT! DO NOT FORCE THE THV. USE SHORT MOVEMENTS TO PREVENT ¿JUMPING¿ OF THE THV INTO THE VENTRICLE. FACTORS THAT CAN MAKE IT DIFFICULT TO CROSS: HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURE, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, INADEQUATE BAV. WHEN EXPERIENCING DIFFICULTY CROSSING: MAKE SURE WIRE IS CORRECTLY EXTENDED AT APEX. PULL TENSION ON THE WIRE OR REPOSITION, ADD SOME DISTAL FLEX OR REMOVE SOME PARTIAL FLEX, PULL SYSTEM BACK AND RE-ADVANCE. DURING THE MANUFACTURING PROCESS, MULTIPLE 100% VISUAL INSPECTIONS ARE PERFORMED THROUGHOUT THE PROCESS. DURING FINAL INSPECTION, THE ENTIRE DEVICE UNDERGOES 100% VISUAL INSPECTION DISTAL TO PROXIMAL BY BOTH MANUFACTURING AND QUALITY. ADDITIONALLY, PRODUCT VERIFICATION (PV) TESTING IS PERFORMED ON A SAMPLING PLAN. THESE INSPECTIONS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. 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. IN THIS CASE, THE COMPLAINT WAS CONFIRMED BASED ON THE AVAILABLE INFORMATION PROVIDED. DUE TO UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO BE PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. THEREFORE, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. A REVIEW OF DHR, LOT HISTORY AND MANUFACTURING MITIGATIONS REVEALED NO INDICATION THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE COMPLAINT. PER EVENT DESCRIPTION, IT WAS MENTIONED THAT ¿THE AORTA WAS A LITTLE TORTUOUS¿ DURING VALVE ALIGNMENT. INFORMATION PROVIDED FROM THE FIELD ALSO INDICATES THAT THE PATIENT DID HAVE A HORIZONTAL AORTA. THE HIGH DEGREE OF AORTIC ANGULATION PRESENT IN A HORIZONTAL AORTA CAN MAKE THE PATHWAY MORE CHALLENGING AS THE DELIVERY SYSTEM TRACKS THROUGH THE ANATOMY. SUBSEQUENTLY THIS CAN LEAD AND CONTRIBUTE TO THE REPORTED DIFFICULTY FELT WHEN ATTEMPTING TO POSITION THE DELIVERY SYSTEM AROUND THE NATIVE ANNULUS. PER THE IMAGERY PROVIDED, AS WELL AS THE CASE DESCRIPTION, THE OPERATOR DID NOTICE THE VALVE WAS NOT AGAINST THE DISTAL MARKER PRIOR TO CROSSING THE ANNULUS. PER CASE DESCRIPTION THERE WAS NO MENTION OF DIFFICULTY IN THE VALVE ALIGNMENT PROCESS. IT IS POSSIBLE DURING THE VALVE ALIGNMENT PROCESS THE OPERATOR DID NOT FULLY ALIGN THE VALVE OVER THE VALVE ALIGNMENT MARKS PRIOR TO CROSSING THE ANNULUS. ALTHOUGH A DEFINITE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED, AVAILABLE INFORMATION SUGGESTS PATIENT FACTORS (VESSEL TORTUOSITY) MAY HAVE CONTRIBUTED TO THE DIFFICULTY CROSSING THE NATIVE VALVE. THE CAUSE OF THE AORTIC DISSECTION IS ALSO UNKNOWN BUT MAY BE DUE TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS (SEVERE VALVULAR CALCIFICATION, TORTUOUS AORTA, HORIZONTAL AORTA). WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS ( TORTUOSITY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME.
PER THE DEVICE¿S INSTRUCTIONS FOR USE DIFFICULTY CROSSING THE NATIVE ANNULUS MAY BE DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS, INCLUDING HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURES, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, AND INCOMPLETE BAV. IN MOST INSTANCES THIS RESOLVES WITH ROUTINE TROUBLESHOOTING MANEUVERS, WITH MINIMAL RISK TO THE PATIENT. THE INSTRUCTIONS FOR USE (IFU) AND THE PROCEDURE DIDACTIC DETAIL THE STEPS NECESSARY TO SUCCESSFULLY CROSS THE NATIVE VALVE AND ALIGN THE TRANSCATHETER HEART VALVE. PER THE PROCEDURE DIDACTIC, IF DIFFICULTY CROSSING IS EXPERIENCED THE OPERATOR IS ADVISED TO PUT TENSION ON THE WIRE AND PULL THE SYSTEM BACK AND RE-ADVANCE. IN ADDITION, THE PROCEDURE DIDACTIC OUTLINES THE STEPS NECESSARY TO ENSURE SMOOTH MOVEMENT OF THE BALLOON CATHETER DURING VALVE ALIGNMENT AND TO MAKE FINE ADJUSTMENTS. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUEING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS EVENT. IN THIS CASE THE CAUSE OF THE DIFFICULTIES CROSSING THE NATIVE ANNULUS IS UNKNOWN BUT MAY BE DUE TO PATIENT FACTORS (AORTIC STENOSIS AND A HORIZONTAL AORTA). THE CAUSE OF THE AORTIC DISSECTION IS ALSO UNKNOWN BUT MAY BE DUE TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS (SEVERE VALVULAR CALCIFICATION, TORTUOUS AORTA, HORIZONTAL AORTA). 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.
AS REPORTED BY OUR AFFILIATE IN DENMARK, A 26MM SAPIEN 3 ULTRA VALVE WAS DEPLOYED IN THE AORTIC POSITION BY THE TRANSFEMORAL APPROACH. PRIOR TO VALVE DEPLOYMENT, PRE-DILATION WAS PERFORMED WITH AN EDWARDS BALLOON AS CROSSING WAS A LITTLE DIFFICULT. THE AORTA WAS ¿A LITTLE¿ TORTUOUS, BUT VALVE ALIGNMENT WENT WELL. UPON ARRIVING AT THE VALVE AREA, THE VALVE WAS AWAY FROM THE DISTAL MARKER, BUT NOT CONSIDERED EXCEEDING THE SIZE OF THE MIDDLE MARKER. THE AORTA WAS ¿CURVED¿ AND THE VALVE WAS PLACED AT AORTIC POSITION WITH THE DISTAL MARKER BELOW THE SAPIEN 3 ULTRA VALVE. CROSSING WAS A LITTLE DIFFICULT DESPITE PRE-DILATION. SHORTLY AFTER VALVE PLACEMENT, A DROP IN BLOOD PRESSURE WAS NOTED. ECHO SHOWED AN AORTIC DISSECTION. DRAINAGE WAS PERFORMED SUCCESSFULLY, AND PATIENT'S BLOOD PRESSURE WAS STABILIZED. SURGICAL REPLACEMENT OF THE DISSECTED AORTA WAS REQUIRED. THE PATIENT WAS TRANSFERRED TO THE OR FOR AN AORTIC GRAFT PLACEMENT. THE PATIENT IS STABLE AND IN GOOD CONDITION. THE SAPIEN 3 ULTRA VALVE REMAINS IMPLANTED IN THE PATIENT AND WAS WORKING AS INTENDED. THE NATIVE ANNULAR VALVE AREA MEASURED 494MM WITH SEVERE LEAFLET CALCIFICATION AND AORTIC WALL CALCIFICATION ON THE LCC SIDE. THE AORTA WAS REPORTED TO BE A LITTLE TORTUOUS AND CURVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1144995 | EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9610TF26U | 62988209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |