EDWARDS COMMANDER DELIVERY SYSTEM
Report
- Report Number
- 2015691-2018-01213
- Event Type
- Malfunction
- Date Received
- April 2, 2018
- Date of Event
- March 9, 2018
- Report Date
- March 9, 2018
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THE COMMANDER DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION REVEALED THE SAPIEN 3 VALVE IN THE SHEATH HOUSING. THE CRIMP BALLOON WAS TORN ADJACENT TO THE I/C (INFLATION/CRIMP BALLOON) BOND AND THE VALVE WAS ON THE INFLATION BALLOON. GOUGES ON THE FLEX TIP WERE ALSO OBSERVED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. DIMENSIONAL ANALYSIS OF THE DOUBLE WALL THICKNESS OF THE CRIMP BALLOON ALONG THE BALLOON TEAR WAS PERFORMED. THE MEASUREMENTS WERE WITHIN SPECIFICATION. LOT HISTORY REVIEW REVEALED NO OTHER COMPLAINTS FOR ¿BALLOON ¿ TORN¿. COMPLAINT HISTORY REVIEW FROM APRIL 2017 THROUGH MARCH 2018 FOR THE EDWARDS COMMANDER DELIVERY SYSTEM (ALL MODELS) REVEALED OTHER RETURNED COMPLAINTS FOR ¿BALLOON ¿ TORN¿. REVIEW OF THE SIMILAR COMPLAINTS WAS DONE AND NO POTENTIAL MANUFACTURING NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINTS WERE IDENTIFIED. A REVIEW OF COMPLAINT DATA REVEALED THAT THE COMPLAINT RATES EXCEEDED THE MARCH 2018 CONTROL LIMIT FOR THE TREND CATEGORY OF ¿DAMAGED¿. 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. TO ADDRESS THE EMERGING TREND IN I/C BOND COMPLAINTS, THE TUBING LOTS AND RESIN FOR HE CRIMP BALLOON UNDERWENT ADDITIONAL REVIEW. THE REVIEW REVEALED A CORRELATION BETWEEN THE INCREASED COMPLAINT RATES AND WITH ALTERNATE EXTRUSION PROCESSING METHODS. THE IFU AND TRAINING MANUALS WERE REVIEWED. NO IFU/TRAINING MANUAL DEFICIENCIES WERE FOUND. DURING THE MANUFACTURING PROCESS, THE ENTIRE DELIVERY SYSTEM (INCLUDING THE CRIMP BALLOON AND INFLATION BALLOON) UNDERGO MULTIPLE VISUAL INSPECTIONS AND TESTING. DURING THE MANUFACTURING PROCESS, THE CRIMP BALLOON, CRIMP BALLOON TO INFLATION BALLOON LASER BOND AND BALLOON CATHETER LASER BOND UNDERGO MULTIPLE 100% INSPECTIONS. PRODUCT VERIFICATION (PV) TESTING WAS ALSO PERFORMED ON EACH LOT USING A SAMPLING PLAN. ALL SAMPLES PASSED PV TESTING. THESE INSPECTIONS SUPPORT THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENT. 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. IT SHOULD BE NOTED THERE WAS NO REPORT OF EMBOLIZATION AND THE VALVE WAS RETRIEVED WITH THE DELIVERY SYSTEM AND SHEATH. A NEW VALVE AND DELIVERY SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN THIS CASE, THE COMPLAINT FOR ¿BALLOON ¿ TORN¿ WAS CONFIRMED BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE. DIMENSIONAL TESTING OF THE CRIMP BALLOON DOUBLE WALL THICKNESS MET SPECIFICATION AND VISUAL INSPECTION OF THE DEVICE DID NOT REVEAL A MANUFACTURING NONCONFORMANCE. AS NO ISSUES WERE NOTED DURING DEVICE PREPPING AND DE-AIRING, THE DEVICE LIKELY HAD NO ISSUES WITH THE BALLOONS OUT OF BOX. AS SUCH, IT IS LIKELY THAT THE TORN CRIMP BALLOON OCCURRED DURING THE PROCEDURE. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THE POTENTIAL ROOT CAUSES FOR TEARING OF THE CRIMP BALLOON MATERIAL PROXIMAL TO THE INFLATION BALLOON TO CRIMP BALLOON BOND HAVE BEEN PREVIOUSLY IDENTIFIED AND DOCUMENTED BY EDWARDS LIFESCIENCES IN A PRODUCT RISK ASSESMENT (PRA), AS PER MANAGEMENT DISCRETION. INCREASED ALIGNMENT FORCES EXPERIENCED DURING THE PROCEDURE AS A POSSIBLE ROOT CAUSE FOR THE BALLOON TEAR. IF THE PHYSICIAN PERFORMED THE VALVE ALIGNMENT PROCESS AT A BEND OR ANGLE, IT COULD RESULT IN INCREASED FORCES BEING APPLIED TO THE BOND AREA. THIS MAY OCCUR AS PERFORMING VALVE ALIGNMENT IN A NON-STRAIGHT SECTION OF THE AORTA CAN CAUSE THE THV TO UNSEAT (NON-COAXIAL PLACEMENT OF THE THV IN RELATION TO THE FLEX TIP) FROM THE FLEX TIP AND ¿DIVE¿ INTO THE LUMEN OF THE FLEX TIP. IF THE THV IS UNSEATED DURING VALVE ALIGNMENT, IT CAN RESULT IN HIGHER THAN USUAL ALIGNMENT FORCES, WEAKENING AND SUBSEQUENTLY TEARING THE BALLOON MATERIAL NEAR THE INFLATION BALLOON TO CRIMP BALLOON BOND. UNDER SIMULATED CONDITIONS (TORTUOUS ANATOMY), A PREVIOUSLY PERFORMED ENGINEERING STUDY WAS ABLE TO RECREATE HIGH VALVE ALIGNMENT FORCES WITH VALVE DIVING. THE FLEX TIP GOUGES NOTED DURING VISUAL INSPECTION ARE INDICATIVE OF VALVE DIVING AND HIGH ALIGNMENT FORCES. AS A RESULT, AVAILABLE INFORMATION SUGGESTS THE ROOT CAUSE FOR THE REPORTED COMPLAINT EVENT MAY BE ATTRIBUTED TO PATIENT FACTORS (TORTUOSITY) AND/OR PROCEDURAL FACTORS (VALVE DIVING). TO ADDRESS THE EMERGING TREND IN I/C BOND COMPLAINTS, THE TUBING LOTS AND RESIN FOR THE CRIMP BALLOON UNDERWENT FURTHER REVIEW. THIS REVIEW IDENTIFIED A CORRELATION BETWEEN RECENT INCREASES IN COMPLAINT RATES WITH ALTERNATE EXTRUSION PROCESSING METHODS. A CAPA WAS PREVIOUSLY INITIATED TO DOCUMENT THE INVESTIGATION OF THIS ISSUE. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED IN THE RETURNED DEVICE. AVAILABLE INFORMATION SUGGESTS THAT PATIENT AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, AT MANAGEMENT DISCRETION, A PRA WAS PREVIOUSLY INITIATED TO DOCUMENT AND ASSESS THE BALLOON TORN AND THE VALVE MOVEMENT ON BALLOON ISSUES AND THE ASSOCIATED RISKS. IN ADDITION, TO ADDRESS THE EMERGING TREND IN IC BOND COMPLAINTS, A CAPA IS BEING UPDATED.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION AND NO IMAGES WERE PROVIDED. A DHR REVIEW FOR THE MOST RELEVANT WORK ORDERS DID NOT REVEAL ANY MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF LOT HISTORY REVEALED NO OTHER COMPLAINTS RELATED TO ¿DELIVERY SYSTEM ¿ LEAKAGE¿. A REVIEW OF COMPLAINT DATA FOR MARCH 2018 REVEALED THAT THE COMPLAINT RATE EXCEEDED THE CONTROL RATE FOR THE APPLICABLE COMPLAINT TREND CATEGORY (¿LEAKAGE¿). BASED ON THE REVIEW OF THE IFU AND TRAINING MANUAL, NO DEFICIENCIES WERE IDENTIFIED. INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. THE COMPLAINT FOR ¿DELIVERY SYSTEM ¿ LEAKAGE¿ WAS UNABLE TO BE CONFIRMED, AS NO RELEVANT PHOTOGRAPHS, VIDEOS, OR IMAGERY WERE PROVIDED. DUE TO THE UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. AS A RESULT, PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. WITHOUT PHOTOGRAPHS, IMAGERY, OR THE DEVICE ITSELF, A DEFINITE SOURCE FOR THE LEAKAGE CANNOT BE DETERMINED. HOWEVER, SINCE THE DEVICE WAS ABLE TO BE SUCCESSFULLY DE-AIRED, IT IS LIKELY THAT THE LEAKAGE SOURCE WAS NOT PRESENT ON THE DEVICE OUT-OF-BOX AND WAS CREATED DURING THE PROCEDURE. THE FOLLOWING PATIENT AND/OR PROCEDURAL FACTORS CAN POSSIBLY CONTRIBUTE TO DELIVERY SYSTEM LEAKAGE: THE CRIMP BALLOON IS TORN AND SEPARATES ADJACENT TO THE I/C BOND. POTENTIAL ROOT CAUSES FOR SEPARATION OF THE CRIMP BALLOON MATERIAL PROXIMAL TO THE I/C BOND HAVE PREVIOUSLY BEEN IDENTIFIED AND DOCUMENTED. PERFORMING VALVE ALIGNMENT IN TORTUOUS ANATOMY COULD RESULT IN INCREASED FORCES BEING APPLIED TO THE BOND AREA CAUSING WEAKENING/SEPARATION ADJACENT TO THE BOND AREA. UNDER SIMULATED CONDITIONS (SIMULATED TORTUOUS ANATOMY), A PREVIOUSLY PERFORMED ENGINEERING STUDY WAS ABLE TO RECREATE HIGH ENOUGH VALVE ALIGNMENT FORCES TO POTENTIALLY CAUSE A MATERIAL FAILURE IN THE AREA IN QUESTION. IN ADDITION, RESIDUAL VOLUME LEFT IN THE BALLOON MAY ALSO CONTRIBUTE TO INCREASED FORCES DURING VALVE ALIGNMENT, WHICH COULD LEAD TO A TEAR IN THE INFLATION AND CRIMP BALLOON BOND. THIS WAS RECREATED IN A PREVIOUSLY PERFORMED ENGINEERING STUDY, WHICH DEMONSTRATED THAT RESIDUAL VOLUME IN THE INFLATION BALLOON DURING VALVE ALIGNMENT CAN CREATE HIGH ENOUGH VALVE ALIGNMENT FORCES TO POTENTIALLY CAUSE A MATERIAL FAILURE IN THE AREA IN QUESTION. EXCESSIVE MANIPULATION OF THE DELIVERY SYSTEM DURING THE PROCEDURE (E.G. DURING DELIVERY SYSTEM INSERTION/ADVANCEMENT OR VALVE ALIGNMENT) RESULTS IN KINKING OR DAMAGE TO THE BALLOON SHAFT OR BALLOON CATHETER BONDS (I.E. NOSE TIP/INFLATION BALLOON, CRIMP BALLOON/BALLOON SHAFT). KINKING OF THE DELIVERY SYSTEM DURING INSERTION/ADVANCEMENT OR IMPROPER INSERTION OF THE STYLET OR GUIDEWIRE RESULTS IN DAMAGE TO THE GUIDEWIRE LUMEN. CALCIFICATION IN THE PATIENT ANATOMY DAMAGES THE INFLATION BALLOON AND/OR CRIMP BALLOON. AS SUCH, IT IS LIKELY THAT PATIENT/PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, BASED ON AVAILABLE INFORMATION, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. 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. SINCE NO MANUFACTURING NON-CONFORMANCE OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE/PREVENTATIVE ACTIONS ARE REQUIRED. ALTHOUGH THE TREND CATEGORY OF ¿LEAKAGE¿ EXCEEDED THE MARCH 2018 CONTROL LIMIT FOR THE COMMANDER DELIVERY SYSTEM, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED DUE TO THE UNAVAILABILITY OF THE DEVICE. ADDITIONALLY, A REVIEW OF COMPLAINTS AND AVAILABLE INFORMATION REVEALED THAT NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING MANUAL DEFICIENCIES HAVE BEEN IDENTIFIED IN RELATION TO THIS ISSUE. AS SUCH, A PRODUCT RISK ASSESSMENT (PRA) ESCALATION IS NOT REQUIRED.
(B)(4). INVESTIGATION IS ONGOING.
AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, DURING THE IMPLANT OF A 26 MM SAPIEN 3 VALVE BY TF APPROACH IN THE AORTIC POSITION WITHOUT BAV, AT THE TIME OF INFLATION, THE VALVE ¿DID NOT OPEN¿ DESPITE MANIPULATION OF THE SYRINGE. DEFLATION WAS INITIATED AND BLOOD WAS SEEN IN THE SYRINGE. THE VALVE WITH THE COMMANDER DELIVERY SYSTEM WERE RETRIEVED INSIDE THE ESHEATH AND THE WHOLE SYSTEM WAS REMOVED TOGETHER. A NEW VALVE AND DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230963 | EDWARDS COMMANDER DELIVERY SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9610TF26 | 61204292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |