EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
Report
- Report Number
- 2015691-2020-12600
- Event Type
- Death
- Date Received
- July 20, 2020
- Date of Event
- June 23, 2020
- Report Date
- June 23, 2020
- 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
THIS INDIVIDUAL REPORT PROVIDES DATA RECEIVED FROM THE THV/TVT REGISTRY. EDWARDS RECEIVED ADDITIONAL INFORMATION FROM THE FIELD CLINICAL SPECIALIST THAT "THE VALVE APPEARED TO BE IN THE CORRECT POSITION WHILE ATTEMPTING VALVE ALIGNMENT. MULTIPLE ATTEMPTS WERE MADE TO MAINTAIN POSITION OF THE VALVE BETWEEN THE VALVE ALIGNMENT MARKERS." THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINED WITH THE HOSPITAL FOR EVALUATION. A NON-PRODUCT RETURN ENGINEERING EVALUATION WAS COMPLETED BY EDWARDS. SUPPLEMENT REPORT SUBMIT TO UPDATE F10, H6, AND ENGINEERING EVALUATION FINDINGS. BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, THE INVESTIGATION WAS BE LIMITED TO THE FOLLOWING ACTIVITIES: REVIEW OF IMAGERY, DHR, LOT HISTORY, SIMILAR COMPLAINTS, IFU, AND MANUFACTURING MITIGATIONS. REVIEW OF RELEVANT IMAGERY SHOWED THAT THE RIGHT SUBCLAVIAN ACCESS VESSEL WAS TORTUOUS AND CALCIFIED. PROCEDURAL CINE IMAGERY REVEALS FLEX SHAFT COMPRESSION AND VALVE DIVING. PROCEDURAL CINE IMAGERY CONFIRMED THAT THE VALVE WAS UNABLE TO BE DEPLOYED. ADDITIONALLY, IT SHOWS THAT THE VALVE WAS NOT PROPERLY ALIGNED BETWEEN THE VALVE ALIGNMENT MARKERS. THE DELIVERY SYSTEM CRIMP BALLOON WAS TORN PROXIMAL TO THE INFLATION BALLOON/CRIMP BALLOON (IC) BOND. THE DISTAL END OF THE DELIVERY SYSTEM WAS ALSO SEPARATED FROM THE NOSE TIP. THE DELIVERY SYSTEM¿S BALLOON PROXIMAL LEGS WERE FLARED OUT AND LIFTED. THE BALLOON SPRING WAS UNRAVELED AND STRETCHED OUT. THE DEVICE HISTORY RECORDS (DHR) WAS REVIEWED AND DID NOT REVEAL ANY MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO A TORN BALLOON, DIFFICULTY WITH VALVE ALIGNMENT, DELIVERY WITHDRAWAL DIFFICULTY, AND NOSE TIP SEPARATION. A REVIEW OF THE COMPLAINT HISTORY FROM JULY 2019 TO JUNE 2020 FOR EDWARDS COMMANDER DELIVERY SYSTEM. THE COMPLAINTS WERE REVIEWED BASED ON SIMILAR REPORTED EVENTS AND ASSOCIATED ROOT CAUSES/EVALUATION CODES. NO MANUFACTURING NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINTS WERE IDENTIFIED DURING THE COMPLAINT HISTORY REVIEW. AVAILABLE INFORMATION SUGGESTED THAT THE TEARS MAY HAVE OCCURRED DURING VALVE ALIGNMENT AND COULD BE ATTRIBUTED TO PATIENT/PROCEDURAL FACTORS. DUE TO THE HIGH CRITICALITY LEVEL FOR THIS FAILURE MODE, A PRODUCT RISK ASSESSMENT WAS PREVIOUSLY INITIATED FOR RISK ASSESSMENT. THE REVIEW OF COMPLAINT DATA FOUND THAT THESE COMPLAINT RATES DID NOT EXCEED THE (B)(6) 2020 CONTROL LIMIT. PER THE IFU FOR EDWARDS COMMANDER DELIVERY SYSTEM, IT STATES, STROKE/TRANSIENT ISCHEMIC ATTACK, CLUSTERS OR NEUROLOGICAL DEFICIT AND EMERGENCY CARDIAC SURGERY ARE POTENTIAL ADVERSE EVENTS. DURING THE MANUFACTURING PROCESS, THE DEVICE WAS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. ALL THE INSPECTIONS ARE CONDUCTED ON 100% OF UNITS, EXCEPT IN THE CASE OF PRODUCT VERIFICATION (PV) TESTING, WHERE THE TESTED UNITS ARE CHOSEN ON A SAMPLING BASIS. ALL TESTED SAMPLE UNITS FOR THIS LOT PASSED PV TESTING. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A 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. THE COMPLAINT FOR BALLOON TORN WAS CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. PER IMAGERY REVIEW, 3MENSIO IMAGERY NOTES THE PRESENCE OF TORTUOSITY IN THE CHOSEN RIGHT SUBCLAVIAN ACCESS. CINE IMAGERY SHOWS COMPRESSION IN THE FLEX SHAFT INDICATING VESSEL TORTUOSITY AND CONSEQUENT TENSION BUILT UP IN THE SYSTEM. THE PRESENCE OF TORTUOSITY CAN RESULT IN VALVE ALIGNMENT AT A BEND OR ANGLE WHICH MAY HAVE LED TO THE VALVE BEING UNSEATED (NON-COAXIALITY PLACEMENT OF VALVE IN RELATION TO THE FLEX TIP) WITH HIGH VALVE ALIGNMENT FORCES, WHICH WAS SEEN IN FIGURE 3 WITH THE VALVE DIVING INTO THE FLEX TIP. IF THE THV IS UNSEATED DURING ALIGNMENT, IT CAN RESULT IN HIGHER VALVE ALIGNMENT FORCES AND CAN LEAD TO TENSION IN THE SYSTEM TO ACHIEVE FINAL VALVE ALIGNMENT POSITION. THIS BUILT-UP TENSION DURING VALVE ALIGNMENT LIKELY ALSO LED TO THE SUBSEQUENT BALLOON TEAR. WHILE A DEFINITIVE ROOT CAUSES UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (TENSION BUILD-UP IN THE SYSTEM) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORT OF WITHDRAWAL DIFFICULTY OF THE DELIVERY SYSTEM WAS CONFIRMED. AS THE CRIMP BALLOON IS SEPARATED PROXIMALLY TO THE IC BOND, THE BALLOON LEGS WOULD HAVE BEEN EXPOSED AND MORE SUSCEPTIBLE TO CATCH ON THE SHEATH DISTAL TIP DURING DELIVERY SYSTEM RETRIEVAL. ADDITIONALLY, VESSEL TORTUOSITY MAY POTENTIALLY LEAD TO NON-COAXIAL RETRIEVAL OF THE DELIVERY SYSTEM WITH THE SHEATH TIP, ESPECIALLY WHEN COMPOUNDED WITH A TORN BALLOON AND EXPOSED BALLOON LEGS. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (VESSEL TORTUOSITY) AND PROCEDURAL FACTORS (PERFORMING VALVE ALIGNMENT IN NON-STRAIGHT SECTION OF AORTA) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE FINDING OF NOSE TIP SEPARATION WAS CONFIRMED. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (EXCESSIVE FORCE/DEVICE MANIPULATION IN RETRIEVING A TORN BALLOON) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, THE COMPLAINTS WERE CONFIRMED, BUT NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE COMPLAINT OCCURRENCE RATES DID NOT EXCEED THE CONTROL LIMIT FOR THE APPLICABLE TREND CATEGORIES AND NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. AS SUCH, NO CORRECTIVE OR PREVENTATIVE ACTION, NOR PRODUCT RISK ASSESSMENT WAS REQUIRED.
SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED. CORRECTED: UF REPORT # (B)(4). WAS RECEIVED.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
AS INITIALLY REPORTED BY THE FIELD CLINICAL SPECIALIST, A 26MM TRANSCATHETER VALVE WAS UNABLE TO BE IMPLANTED DUE TO THE BALLOON ON THE DELIVERY SYSTEM NOT BEING ABLE TO INFLATE. THE VALVE WAS DELIVERED THROUGH THE RIGHT SUBCLAVIAN ARTERY APPROACH. PROPER VALVE ALIGNMENT WAS PERFORMED IN THE USUAL POSITION IN THE ASCENDING AORTA. THE VALVE WAS POSITIONED IN THE NATIVE CALCIFIED AORTIC VALVE. DEGREE OF CALCIUM WAS NOTED TO BE MILD. A BAV WAS NOT USED. THERE WASN¿T ANY RESISTANCE THAT THE THEY WERE AWARE OF. WHEN THE BALLOON WAS INFLATED ON THE DELIVERY SYSTEM THEY NOTICED THAT THE VALVE WAN NOT EXPANDING. THEY PULLED NEGATIVE ON THE INFLATION DEVICE AND NOTICED BLOOD IN THE SYRINGE WHICH WAS INDICATIVE OF A BURST BALLOON. IT WAS THEN WE REALIZED THE BALLOON HAD A HOLE WHICH PREVENTED EXPANSION OF THE VALVE. THE ROOT CAUSE OF BALLOON TEAR WAS UNKNOWN. A MINI THORACOTOMY TO SAFELY REMOVE THE VALVE WAS PERFORMED. A SECOND VALVE WAS NOT DEPLOYED. THE PATIENT SEEMED TO BE DOING FINE AT THE END OF THE PROCEDURE. HOWEVER, THE PATIENT EXPIRED ON POST-OPERATIVE DAY #2 DUE TO PROLONGED RIGHT HEMISPHERIC CEREBRAL ISCHEMIC TIME. AS REPORTED BY THE OPERATOR, THE VALVE WAS UNABLE TO BE DEPLOYED DUE TO A BALLOON TEAR. THE BALLOON TEAR AND ITS LOCATION SUGGESTS THAT IT WAS CAUSED BY THE LEADING EDGE OF THE CRIMPED STENT FRAME WHEN MAKING THE EXTRAORDINARY EFFORT TO MOUNT THE VALVE IN THE CENTER OF THE BALLOON. THIS COMPLICATION RESULTED IN INABILITY TO REMOVE THE VALVE AND DELIVERY SYSTEM AND ULTIMATELY THE PATIENT¿S DEMISE FROM PROLONGED RIGHT HEMISPHERIC CEREBRAL ISCHEMIC TIME.
UDI: (B)(4). THE INVESTIGATION IS STILL IN PROGRESS.
AS REPORTED BY AN EDWARDS FIELD CLINICAL SPECIALIST(FCS), A 26MM SAPIEN 3 ULTRA VALVE WAS UNABLE TO BE IMPLANTED DUE TO THE BALLOON ON THE COMMANDER DELIVERY SYSTEM NOT BEING ABLE TO INFLATE. THE VALVE WAS DELIVERED THROUGH THE RIGHT SUBCLAVIAN ARTERY APPROACH. PROPER VALVE ALIGNMENT WAS PERFORMED IN THE USUAL POSITION IN THE ASCENDING AORTA. THE VALVE WAS POSITIONED IN THE NATIVE CALCIFIED AORTIC VALVE. DEGREE OF CALCIUM WAS NOTED TO BE MILD. A BAV WAS NOT USED. THERE WASN¿T ANY RESISTANCE THAT THE THEY WERE AWARE OF. WHEN THE OPERATOR STARTED TO INFLATE THE BALLOON ON THE COMMANDER DELIVERY SYSTEM, THE VALVE WAN NOT EXPANDING. THE OPERATOR PULLED NEGATIVE ON THE INFLATION DEVICE AND NOTICE BLOOD IN THE SYRINGE. IT WAS THEN REALIZED THE BALLOON HAD A HOLE WHICH PREVENTED EXPANSION OF THE VALVE. THE ROOT CAUSE OF BALLOON TEAR WAS UNKNOWN. A MINI THORACOTOMY WAS PERFORMED TO SAFELY REMOVE THE VALVE. A SECOND VALVE WAS NOT DEPLOYED. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. HOWEVER, THE PATIENT EXPIRED ON POD #2 DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763688 | EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY | NPT | EDWARDS LIFESCIENCES | 9750CM26A | 63009618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death| R |