EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2020-12510
- Event Type
- Malfunction
- Date Received
- July 13, 2020
- Date of Event
- May 12, 2020
- Report Date
- June 24, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
ADDITIONAL INFORMATION: THE INITIAL 14FR ESHEATH, 26MM COMMANDER DELIVERY SYSTEM AND 26MM SAPIEN 3 ULTRA VALVE WERE RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION OF THE DEVICES REVEALED VALVE STRUTS PUNCTURED THE SHEATH STRAIN RELIEF AND WERE EXPOSED APPROXIMATELY 3 INCHES FROM THE COMNUT. ONE STRUT WAS BENT OUTWARD ON THE VALVE INFLOW SIDE. FOLLOWING THE EXPANSION OF THE VALVE, ONE STRUT WAS SLIGHTLY BENT ON THE VALVE INFLOW SIDE NEAR C3. THE FRAME WAS DISTORTED AND DAMAGED. ALL STRUTS WERE EXPOSED THROUGH THE SKIRT, HOWEVER THIS IS NORMAL AFTER CRIMPING AND USE. GOUGES WERE OBSERVED ON THE FLEX TIP. NO IMAGERY WAS PROVIDED FOR REVIEW. NO FUNCTIONAL TESTING OR DIMENSIONAL ANALYSIS WERE ABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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. VALVE COMPLAINTS REFERENCE THE VALVE SERIAL NUMBER ONLY. THEREFORE, THIS REVIEW WAS PERFORMED BY TAKING THE VALVE SERIAL NUMBERS (7232618 THROUGH 7232627) FROM THE SAME WORK ORDER AND VERIFYING THAT THERE HAVE BEEN NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THOSE SERIAL NUMBERS. COMPLAINT HISTORY REVIEW WAS NOT REQUIRED AS THE ISSUE HAS BEEN PREVIOUSLY IDENTIFIED IN A PRODUCT RISK ASSESSMENT (PRA), WHICH CAPTURED THE ROOT CAUSE ANALYSIS FOR THE ISSUE. THE IFU, DEVICE PREPARATION TRAINING MANUAL, PROCEDURAL TRAINING MANUAL, AND PROCEDURAL MANUAL WERE REVIEWED FOR GUIDANCE INVOLVING ESHEATH AND DELIVERY SYSTEM USAGE. THE USER IS INSTRUCTED TO ENSURE ADEQUATE VESSEL ACCESS AND NOT TO USE THE ESHEATH IN TORTUOUS OR CALCIFIED VESSELS THAT WOULD PREVENT SAFE ENTRY OF THE SHEATH. ADDITIONAL CONSIDERATIONS INCLUDE PROPER SCREENING AS THIS IS CRITICAL TO REDUCE VASCULAR COMPLICATIONS. PUSH FORCE CAN VARY DUE TO ANGLE OF INSERTION, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIUM. DO NOT FORCE SHEATH. REGARDING DELIVERY SYSTEM INSERTION THROUGH SHEATH: ORIENT THE DELIVERY SYSTEM WITH THE FLUSH PORT POINTING AWAY AND THE EDWARDS LOGO FACING UP, ENSURE DELIVERY SYSTEM IS LOCKED IN DEFAULT POSITION. INSERTION FORCE THROUGH THE PARTIALLY EXPANDABLE PORTION CAN BE HIGHER THAN THE PUSH FORCE THROUGH THE FULLY EXPANDABLE PORTION. PUSH FORCE CAN VARY DUE TO ANGLE OF INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH WHILE ADVANCING THE THV/DELIVERY SYSTEM 1-2 CM. IN EXPECTATION OF HIGH FRICTION, USE SHORT MOVEMENTS. IF WORKING LENGTH IS INSUFFICIENT, PEEL AWAY THE LOADER TUBE AND REMOVE WHILE MAINTAINING DELIVERY SYSTEM AND WIRE POSITION. DURING THE MANUFACTURING PROCESS, DURING INCOMING INSPECTION, THE VALVE FRAMES UNDERGO 100% VISUAL AND DIMENSIONAL INSPECTIONS BY MANUFACTURING AND QUALITY. FOLLOWING THE CLEANING AND DRYING CYCLE, THE VALVE FRAMES UNDERGO 100% VISUAL INSPECTION UNDER A MINIMUM 10X MAGNIFICATION. THE LOT MET THE STATISTICAL ACCEPTANCE CRITERIA AS THE CALCULATED LOWER TOLERANCE LIMIT (LTL) AND/OR UPPER TOLERANCE LIMIT (UTL) OF EACH TESTING FALL WITHIN THE RESPECTIVE LOWER SPECIFICATION LIMIT (LSL) AND/OR UPPER SPECIFICATION LIMIT (USL). DURING MANUFACTURING, ALL SAPIEN 3 ULTRA VALVE ASSEMBLIES UNDERGO MULTIPLE 100% VISUAL INSPECTIONS. DURING FINAL ASSEMBLY, THE VALVE UNDERGOES 100% VISUAL INSPECTION BEFORE AND AFTER HOLDER ATTACHMENT. THESE INSPECTIONS 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. IN THIS CASE, THE COMPLAINT WAS CONFIRMED BASED ON THE VISUAL INSPECTION OF THE RETURNED VALVE. NO POTENTIAL MANUFACTURING NON-CONFORMANCE WERE IDENTIFIED. A REVIEW OF THE LOT HISTORY, DHR, MANUFACTURING MITIGATIONS AND COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATIONS THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. AS REPORTED, ¿THE INSERTION OF A 26MM SAPIEN 3 ULTRA VALVE AND COMMANDER DELIVERY SYSTEM WAS DIFFICULT DUE TO THE ¿TOUGH¿ TISSUE. THE VALVE AND DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE ¿WHITE SECTION¿ OF THE ESHEATH¿. THE TOUGH TISSUE CAN PREVENT THE SHEATH FROM FULLY EXPANDING, AND LEAD TO HIGH PUSH FORCE TO ADVANCE THE DELIVERY SYSTEM/VALVE THROUGH THE SHEATH. SO, IF EXCESSIVE MANIPULATION/FORCE WAS APPLIED TO ADVANCE THE DELIVERY SYSTEM WITH THE CRIMPED VALVE, IT CAN LEAD TO THE VALVE STRUT TO CATCH WITHIN THE SHEATH AND PUNCTURED THROUGH THE SHEATH. THE GOUGES ON FLEX TIP INDICATES THE EXCESSIVE MANIPULATION, AND THE MANIPULATION BETWEEN THE SHEATH AND VALVE CAN RESULT IN THE BENT STRUT AT THE VALVE INFLOW. PER TRAINING MANUAL, ¿PUSH FORCE CAN VARY DUE TO ANGLE OF ACCESS AND INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION¿, ¿IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH 1-2 CM WHILE ADVANCING THE THV/DELIVERY SYSTEM¿ AND ¿DO NOT OVER-MANIPULATE THE SHEATH AT ANY TIME¿. ALTHOUGH A DEFINITE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT IN ADDITION TO PROCEDURAL FACTORS (EXCESSIVE DEVICE MANIPULATION), PATIENT FACTORS (VESSEL SCAR TISSUE) MAY HAVE CONTRIBUTED TO THE INSERTION DIFFICULTIES AND DAMAGED VALVE FRAME. ALTHOUGH NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED, PER MANAGEMENT DISCRETION, A PRA AND CAPA WERE PREVIOUSLY INITIATED TO CAPTURE THE CAPTURE FURTHER INVESTIGATION AND CORRECTIVE/PREVENTIVE ACTION ACTIVITIES. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-12635.
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 REPORTED, DURING A TRANSFEMORAL TAVR PROCEDURE, A 14FR ESHEATH WAS INSERTED INTO THE PATIENT, BUT THE TISSUE AT THE ACCESS SITE WAS REPORTED TO BE ¿TOUGHER THAN NORMAL¿ DUE TO SCAR TISSUE AT THE SITE. THE INSERTION OF A 26MM SAPIEN 3 ULTRA VALVE AND COMMANDER DELIVERY SYSTEM WAS DIFFICULT DUE TO THE ¿TOUGH¿ TISSUE. THE VALVE AND DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE ESHEATH. THE ESHEATH, DELIVERY SYSTEM AND VALVE WERE REMOVED. A NEW ESHEATH, 26MM SAPIEN 3 ULTRA VALVE AND DELIVERY SYSTEM WERE PREPARED AND USED FOR THE PROCEDURE. THE NEW VALVE WAS SUCCESSFULLY DEPLOYED IN THE INTENDED POSITION. NO CONSEQUENCES TO THE PATIENT WERE REPORTED. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. THE SECOND VALVE REMAINS IMPLANTED IN THE PATIENT. THE INITIAL SHEATH, VALVE AND DELIVERY SYSTEM WERE RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DURING THE PRE-DECONTAMINATION EVALUATION OF THE DEVICES, DAMAGE TO THE VALVE FRAME WAS OBSERVED ON THE RETURNED VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726483 | EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750TFX26A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |