EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
Report
- Report Number
- 2015691-2020-13032
- Event Type
- Death
- Date Received
- August 11, 2020
- Date of Event
- July 21, 2020
- Report Date
- July 21, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION: SECTION H6: EVALUATION CODES; SECTION H10: NARRATIVE TEXT. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE 26MM 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. NO RELEVANT PHOTOGRAPHS OR CASE IMAGERY WAS PROVIDED FOR REVIEW. 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-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT HISTORY REVIEW REVEALED NO OTHER SIMILAR COMPLAINTS. AS THE COMPLAINT WAS NOT ABLE TO BE CONFIRMED, A COMPLAINT HISTORY REVIEW WAS NOT REQUIRED. PER THE IFU AND TRAINING MANUALS, IF A BALLOON BURST OCCURS, 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 GETTING RESISTANCE, GOING IN WITH A SNARE AND COMPRESSING THE DISTAL END OF THE TORN BALLOON TO PREVENT IT FROM ¿UMBRELLA-ING¿ AT THE TIP OF THE SHEATH COULD HELP. UNDERSTANDING WHERE THE TEAR IS MAY HELP IN THIS CASE. IF SUCCESSFUL IN PULLING THE ENTIRE BALLOON INTO THE TIP OF THE SHEATH, WITHDRAW THE CATHETER/DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION.DO NOT ATTEMPT TO PULL JUST THE CATHETER/DELIVERY SYSTEM THROUGH THE SHEATH. IF YOU ARE NOT ABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, DO NOT ATTEMPT TO REMOVE THE EXPOSED BALLOON THROUGH THE VASCULATURE. RISK OF MAJOR COMPLICATION IS TOO HIGH. CONVERT TO SURGERY IMMEDIATELY. IT SHOULD BE SURGICALLY REMOVED. SURGEON SHOULD BE IN A POSITION TO BE ABLE TO EVALUATE THE SITUATION BEFORE A REAL BLEEDING EMERGENCY OCCURS. NO IFU/TRAINING MANUAL DEFICIENCIES WERE FOUND. 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. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT. THERE ARE EXTENSIVE MANUFACTURING INSPECTIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING PERFORMED TO EVERY MANUFACTURED LOT). THE THV DELIVERY SYSTEM BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST DUE TO CONTACT WITH A HIGHLY CALCIFIED ANNULUS. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE NATIVE ANNULAR CALCIFICATION AT FULL INFLATION/DEPLOYMENT. IN THIS CASE, THE COMPLAINT WAS NOT ABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. REVIEWS OF DHR AND LOT HISTORY REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE EVENT. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. THE COMPLAINT DESCRIPTION STATES THAT ¿ATTEMPTS WERE MADE TO DEPLOY THE VALVE IN THE ASCENDING AORTA USING THE COMMANDER DELIVERY SYSTEM USED FOR THE VALVE DEPLOYMENT. DURING THE ATTEMPT, ADDITIONAL VOLUME WAS ADDED TO THE DELIVERY SYSTEM, RESULTING IN A BALLOON BURST¿. PER THE TRAINING MANUAL, WHEN MANAGING AORTIC EMBOLIZATION, ¿DO NOT FULLY INFLATE BALLOON DUE TO RISK OF AORTIC DISSECTION¿. IT IS LIKELY THAT OVER INFLATION OF THE BALLOON WITH THE ADDITIONAL VOLUME COULD HAVE RESULTED IN INCREASED INFLATION PRESSURES, RESULTING IN THE BALLOON BURST. ADDITIONALLY, THE CONDITION OF THE ATTEMPTED LANDING ZONE OF THE BALLOON BURST EVENT IS UNKNOWN (DEGREE OF CALCIFICATION); THEREFORE, IT IS POSSIBLE THAT OTHER PATIENT FACTORS CONTRIBUTED TO THE BALLOON BURST. ALTHOUGH A DEFINITE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS PROCEDURAL FACTORS (OVER INFLATION OF THE BALLOON) MAY HAVE CONTRIBUTED TO THE BALLOON BURST DURING THE ATTEMPTS TO RECAPTURE THE EMBOLIZED VALVE. 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 AT THIS TIME. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (OVER INFLATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. AS SUCH, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-13033.
CORRECTED DATA: F10, H6. REFERENCE (B)(4).
ADDITIONAL INFORMATION: SECTION H6: EVALUATION CODES; SECTION H10: NARRATIVE TEXT. THE COMMANDER DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION REVEALED THE BURST BALLOON WAS WITHIN THE SHEATH HOUSING. THE SHEATH HOUSING WAS DISASSEMBLED TO REMOVE THE BURST BALLOON FOR THE SHEATH. THE DISTAL PORTION OF THE INFLATION BALLOON WAS STUCK IN THE COMNUT AND STRAIN RELIEF PORTION OF THE SHEATH. THE BALLOON SPRING WAS BUNCHED UP. FOLLOWING REMOVAL FROM THE SHEATH, THE BALLOON MATERIAL WAS FOUND TO BE BUNCHED UP AND FULLY FOLDED OVER THE DISTAL NOSE TIP. THE BALLOON BURST WAS RADIALLY AND LONGITUDINALLY ACROSS THE WORKING LENGTH. NO MISSING BALLOON PIECES WERE REPORTED. NO RELEVANT CASE IMAGERY WAS RECEIVED FOR REVIEW. DIMENSIONAL ANALYSIS OF THE BALLOON SINGLE WALL THICKNESS ALONG THE EDGES OF THE BURST LOCATION WAS PERFORMED. ALL MEASUREMENTS MET SPECIFICATION. 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-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LOT HISTORY REVIEW REVEALED NO OTHER SIMILAR COMPLAINTS. COMPLAINT HISTORY REVIEW FROM SEPTEMBER 2019 TO AUGUST 2020 FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED OTHER SIMILAR REPORTED EVENTS FOR THE ASSOCIATED ROOT CAUSE/EVALUATION CODES. AVAILABLE INFORMATION SUGGESTS THAT PATIENT/PROCEDURAL FACTORS (OVER-INFLATION OF BALLOON, REUSED DEVICE, FLEX TIP NOT RETRACTED DURING DEPLOYMENT, AND/OR STENT, ANNULUS CALCIFICATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. PER THE INSTRUCTIONS FOR USE (IFU) AND TRAINING MANUALS, IF A BALLOON BURST OCCURS, 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 GETTING RESISTANCE, GOING IN WITH A SNARE AND COMPRESSING THE DISTAL END OF THE TORN BALLOON TO PREVENT IT FROM 'UMBRELLA-ING' AT THE TIP OF THE SHEATH COULD HELP. UNDERSTANDING WHERE THE TEAR IS MAY HELP IN THIS CASE. IF SUCCESSFUL IN PULLING THE ENTIRE BALLOON INTO THE TIP OF THE SHEATH, WITHDRAW THE CATHETER/DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT ATTEMPT TO PULL JUST THE CATHETER/DELIVERY SYSTEM THROUGH THE SHEATH. IF YOU ARE NOT ABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, DO NOT ATTEMPT TO REMOVE THE EXPOSED BALLOON THROUGH THE VASCULATURE. RISK OF MAJOR COMPLICATION IS TOO HIGH. CONVERT TO SURGERY IMMEDIATELY. IT SHOULD BE SURGICALLY REMOVED. SURGEON SHOULD BE IN A POSITION TO BE ABLE TO EVALUATE THE SITUATION BEFORE A REAL BLEEDING EMERGENCY OCCURS. NO IFU/TRAINING MANUAL DEFICIENCIES WERE FOUND. 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 ABLE TO BE CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE. HOWEVER, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED IN THE RETURNED DEVICE (BALLOON WALL THICKNESS MEASUREMENT MET THE SPECIFICATION PER DRAWING). REVIEWS OF DHR, LOT HISTORY, COMPLAINT HISTORY AND MANUFACTURING NON-CONFORMANCE SUPPORTED THAT A MANUFACTURING MITIGATIONS LIKELY DID NOT CONTRIBUTE TO THE REPORTED EVENTS. THE COMPLAINT DESCRIPTION STATES THAT ¿ATTEMPTS WERE MADE TO DEPLOY THE VALVE IN THE ASCENDING AORTA USING THE COMMANDER DELIVERY SYSTEM USED FOR THE VALVE DEPLOYMENT. DURING THE ATTEMPT, ADDITIONAL VOLUME WAS ADDED TO THE DELIVERY SYSTEM, RESULTING IN A BALLOON BURST¿. PER TRAINING MANUAL DOC-0125903 REV. D, WHEN MANAGING AORTIC EMBOLIZATION, 'DO NOT FULLY INFLATE BALLOON DUE TO RISK OF AORTIC DISSECTION'. IT IS LIKELY THAT OVER INFLATION OF THE BALLOON WITH THE ADDITIONAL VOLUME COULD HAVE RESULTED IN INCREASED INFLATION PRESSURES, RESULTING IN THE BALLOON BURST. ADDITIONALLY, THE CONDITION OF THE ATTEMPTED LANDING ZONE OF THE BALLOON BURST EVENT IS UNKNOWN (DEGREE OF CALCIFICATION); THEREFORE, IT IS POSSIBLE THAT OTHER PATIENT FACTORS CONTRIBUTED TO THE BALLOON BURST. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (OVER INFLATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME.
UDI NUMBER: (B)(4). EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.
AS INITIALLY REPORTED, DURING A TRANSFEMORAL TAVR PROCEDURE, DURING THE DEPLOYMENT OF A 26MM SAPIEN 3 ULTRA VALVE, PACING CAPTURE FAILED TO DROP THE SYSTOLIC BLOOD PRESSURE TO AN APPROPRIATE LEVEL, RESULTING IN THE EMBOLIZATION OF THE VALVE INTO THE AORTA. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RECAPTURE THE VALVE AND REPOSITION IT TO A ¿SAFE¿ POSITION. DUE TO THE FAILURE TO REPOSITION THE VALVE AND THE CRITICAL CONDITION OF THE PATIENT, THE PROCEDURE WAS CONVERTED TO EMERGENCY OPEN SURGERY. THE SAPIEN 3 ULTRA VALVE WAS EXPLANTED AND A SURGICAL AORTA VALVE WAS IMPLANTED. ADDITIONAL INFORMATION AND MEDICAL RECORD REVIEW REVEALED DURING RAPID PACING FOR THE DEPLOYMENT OF THE SAPIEN 3 ULTRA VALVE, THE PATIENT COUGHED, AND A PVC OCCURRED, RESULTING IN LOSS OF PACING CAPTURE. THE VALVE EMBOLIZED INTO THE ASCENDING AORTA. SEVERAL UNSUCCESSFUL ATTEMPTS TO RECAPTURE THE VALVE AND MOVE IT TO THE DESCENDING AORTA. WHEN THIS FAILED, ATTEMPTS WERE MADE TO DEPLOY THE VALVE IN THE ASCENDING AORTA USING THE SAME COMMANDER DELIVERY SYSTEM AS USED FOR THE VALVE DEPLOYMENT. DURING THE ATTEMPTS, SIGNIFICANT ADDITIONAL VOLUME WAS ADDED TO THE DELIVERY SYSTEM, RESULTING IN A BALLOON BURST. SEVERAL OTHER LARGE BALLOONS WERE ALSO USED TO OVER EXPAND THE VALVE; HOWEVER, THE VALVE WAS NOT STABLE AND MOVED FREELY IN THE ASCENDING AORTA. AT THIS TIME THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED. FOLLOWING THE ARCH REPLACEMENT AND IMPLANT OF A SURGICAL VALVE, THE ESHEATH WAS REMOVED AND THE ACCESS SITE WAS REPAIRED. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION, WITH STABLE CARDIAC FUNCTION. POST PROCEDURE, THE PATIENT EXPIRED. THE EXACT DATE AND CAUSE OF DEATH WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853679 | EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750CM26A | 63131044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |