UNKNOWN EDWARDS DELIVERY SYSTEM
Report
- Report Number
- 2015691-2018-03405
- Event Type
- Malfunction
- Date Received
- August 16, 2018
- Date of Event
- July 28, 2015
- Report Date
- July 26, 2018
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THE AFFECTED DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. NO RELEVANT PHOTOGRAPHS, VIDEOS, OR IMAGERY WERE PROVIDED. A DEVICE HISTORY RECORDS (DHR) AND LOT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS WORK ORDER INFORMATION WAS NOT PROVIDED. COMPLAINT DATA FOR THE PREVIOUS 12 MONTHS (AUGUST 2017 THROUGH JULY 2018) WAS REVIEWED FOR THE COMMANDER DELIVERY SYSTEM (ALL MODELS AND SIZES) REVEALED OTHER SIMILAR COMPLAINTS THAT WERE CONFIRMED. NO MANUFACTURING NON-CONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENTS WERE IDENTIFIED DURING THE INVESTIGATION OF THESE SIMILAR COMPLAINTS. AVAILABLE INFORMATION SUGGESTED THAT THE FOLLOWING PATIENT/PROCEDURAL FACTORS MAY HAVE BEEN CONTRIBUTING FACTORS: VALVE ALIGNMENT IN NON-STRAIGHT SECTION; OVER-INFLATION OF BALLOON; CALCIFICATION; TORTUOSITY; PERFORATION DURING WITHDRAWAL; REMOVAL OF BALLOON COVER USING TOOLS. A REVIEW OF COMPLAINT DATA FOR JULY 2018 REVEALED THAT THE COMPLAINT RATE DID NOT EXCEED THE CONTROL LIMIT FOR THE APPLICABLE COMPLAINT TREND CATEGORY. IT SHOULD BE NOTED THAT THE SAPIEN 3 (S3) WITH THE COMMANDER DELIVERY SYSTEM (DS) IS ONLY INDICATED FOR NATIVE AORTIC VALVE REPLACEMENT IN GERMANY. THE IFU AND TRAINING MANUALS IN THIS SECTION ARE FOR A TF PROCEDURE IN THE AORTIC POSITION AND WERE REVIEWED FOR RELEVANT GUIDANCE INVOLVING DELIVERY SYSTEM USAGE. BASED ON THE REVIEW OF THE IFU AND TRAINING MANUAL, NO DEFICIENCIES WERE IDENTIFIED. SINCE WORK ORDER INFORMATION WAS NOT PROVIDED, DOCUMENTS PRESENTED BELOW ARE IN THE EVENT OCCURRENCE DATE REVISIONS ((B)(6) 2015). THE DESCRIBED PROCESS IS REPRESENTATIVE OF THE MANUFACTURING PROCESSES UNDERGONE BY THE COMPLAINT DEVICE. DURING MANUFACTURING, MULTIPLE VISUAL INSPECTIONS AND TESTS ARE PERFORMED THROUGHOUT THE PROCESS. INFLATION BALLOONS ARE 100% INSPECTED FOR THE WORKING LENGTH, BALLOON DIAMETER, PROXIMAL AND DISTAL LEG IDS, PROXIMAL LEG OD, AND DOUBLE WALL THICKNESS. THE CRIMP BALLOON FEATURES ARE 100% DIMENSIONALLY INSPECTED INCLUDING THE DISTAL LENGTH, PROXIMAL LENGTH, DISTAL ID, PROXIMAL ID, AND SINGLE OR DOUBLE WALL THICKNESS. THE BALLOONS ARE 100% VISUALLY INSPECTED WITH UNAIDED EYE FOR GENERAL APPEARANCE/GROSS DEFECTS. THE BALLOONS ARE 100% VISUALLY INSPECTED UNDER 8X MAGNIFICATION FOR FOREIGN MATTER, IMPURITY OR CONTAMINATION, FISH EYES, GEL SPOTS, ETC. THE LASER WELD JOINT IS 100% VISUALLY INSPECTED FOR BUBBLES AND TO ENSURE THERE IS A SMOOTH BOND JOINT WITH NO GAPS BETWEEN COMPONENTS. THE BALLOON ASSEMBLY IS 100% VISUALLY INSPECTED PRIOR TO LASER BONDING FOR ANY CONTAMINATION. THE CRIMP BALLOON TO BALLOON SHAFT BOND JOINT IS VISUALLY INSPECTED FOR DIVOTS, BUBBLES, BRAIDED WIRE EXPOSED WITHIN 7MM OF BALLOON SHAFT DISTAL END, LEAK CHANNELS, AND WELD JOINT FOR SMOOTHNESS. THE NOSE TIP TO BALLOON BOND JOINT IS VISUALLY INSPECTED FOR BUBBLES, NECK DOWN AROUND NOSE TIP, DIVOTS, LEAK CHANNELS, AND WELD JOINT FOR SMOOTHNESS. THE SPRING COIL IS VISUALLY INSPECTED AND REJECTED FOR BENT COILS. PRIOR TO THE PLEAT FOLDING PROCESS, THE BALLOON IS 100% VISUALLY INSPECTED UNDER 2.85X MINIMUM MAGNIFICATION FOR BALLOON SIZE AND CONTAMINATION. AFTER THE PROCESS, THE BALLOON IS 100% VISUALLY INSPECTED FOR FOLD LINES AND REJECTED FOR DISTORTED/PINCHED FOLDS. 100% DISTAL TO PROXIMAL VISUAL INSPECTION IS PERFORMED BY BOTH MANUFACTURING AND QUALITY. THE ENTIRE DEVICE IS INSPECTED FOR DAMAGE OR MISSING COMPONENTS. THE INFLATION AND CRIMP BALLOONS ARE INSPECTED AND REJECTED FOR DISTORTED/PINCHED FOLDS. THE COMMANDER DELIVERY SYSTEM IS 100% LEAK TESTED. POST-LEAK TEST, THERE IS A VISUAL INSPECTION OF THE INFLATION BALLOON ADDITIONALLY, EACH LOT IS REQUIRED TO UNDERGO PRODUCT VERIFICATION (PV) TEST, AND ONLY THE LOT THAT PASSED THE PV TEST WOULD BE RELEASED FOR DISTRIBUTION. IT IS VISUALLY INSPECTED FOR PHYSICAL DEFECTS OR DAMAGE, AND BURST PRESSURE AFTER FATIGUE. BALLOON/NOSE TIP TENSILE TEST IS ALSO PERFORMED, AS WELL AS INFLATION BALLOON/CRIMP BALLOON TENSILE TEST AND CRIMP BALLOON/BALLOON SHAFT TENSILE TEST. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT DAMAGE ON THE DELIVERY SYSTEM WAS PRESENT WHEN LEAVING THE MANUFACTURING FACILITY. DUE TO THE DEVICE NOT BEING RETURNED AND NO IMAGERY BEING PROVIDED, THE COMPLAINT FOR BALLOON LEAKAGE WAS UNABLE TO BE CONFIRMED. SINCE THE DEVICE WAS NOT RETURNED, IT WAS NOT POSSIBLE TO DETERMINE IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. HOWEVER, REVIEW OF MANUFACTURING MITIGATIONS AND COMPLAINT HISTORY SUGGESTS THAT A MANUFACTURING NON-CONFORMANCE DID NOT CONTRIBUTE TO THE COMPLAINT. 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. PATIENT/PROCEDURAL FACTORS THAT CAN RESULT IN BALLOON LEAKAGE. 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). CALCIFICATION IN THE PATIENT ANATOMY DAMAGES THE INFLATION BALLOON AND/OR CRIMP BALLOON. THOUGH THE LOCATION OF THE LEAK COULD NOT BE CONFIRMED, ONE POTENTIAL CAUSE OF THE LEAK MAY HAVE BEEN A TEAR IN THE CRIMP BALLOON. PREVIOUS COMPLAINTS HAVE SHOWN THAT THE AREA OF THE CRIMP BALLOON PROXIMAL TO THE INFLATION BALLOON/CRIMP BALLOON BOND CAN BECOME DAMAGED/WEAKENED DURING VALVE ALIGNMENT. PERFORMING ALIGNMENT IN A NON-STRAIGHT AREA COULD RESULT IN INCREASED FORCES BEING APPLIED TO THE BOND AREA CAUSING DAMAGE 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 AREA PROXIMAL TO 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. AS SUCH, IT IS POSSIBLE 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. THE COMPLAINT FOR BALLOON LEAKAGE WAS UNABLE TO BE CONFIRMED. DUE TO THE UNAVAILABILITY OF THE DEVICE, IT CANNOT BE CONFIRMED IF A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO DETERMINE AT THIS TIME, BUT IT IS POSSIBLE THAT PATIENT/PROCEDURAL FACTORS (CALCIFICATION/TORTUOSITY, EXCESSIVE MANIPULATION, AND/OR ALIGNMENT IN A NON-STRAIGHT SECTION) CONTRIBUTED TO THE REPORTED EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED AND REVIEW OF COMPLAINT HISTORY REVEALED THAT THE COMPLAINT RATE DID NOT EXCEED THE MONTHLY CONTROL LIMITS FOR THE TREND CATEGORY. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT (PRA) ESCALATION NOR CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THE EXACT FAILURE MODE OF THE COMPLAINT WAS UNABLE TO BE DETERMINED, IT MAY BE RELATED TO A PRA AND A CAPA THAT WERE PREVIOUSLY OPENED. THESE DOCUMENTS ADDRESS THE CRIMP BALLOON TORN FAILURE MODE.
CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.
AS REPORTED BY OUR AFFILIATES IN GERMANY, PER ARTICLE: "PERCUTANEOUS PULMONARY VALVE IMPLANTATION FOR RECONSTRUCTION OF A PATCH-REPAIRED RIGHT VENTRICULAR OUTFLOW TRACT", BETWEEN MARCH 2007 AND MARCH 2017, 7 PATIENTS RECEIVED A PPVI (PERCUTANEOUS PULMONARY VALVE IMPLANTATION) WITH A SAPIEN¿ VALVE TO REPAIR CONDUIT-FREE, PATCH AUGMENTED RVOT (RIGHT VENTRICULAR OUTFLOW TRACT). IN ONE CASE THE DELIVERY SYSTEM OF A SAPIEN¿ VALVE COULD NOT BE USED DUE TO A DEFECTIVE BALLOON, SO THE ENTIRE SYSTEM HAD TO BE REMOVED AND REPLACED BY A NEW ONE. AS PER INFORMATION RECEIVED, THIS WAS A 29MM SAPIEN 3 CASE IN PULMONIC POSITION (OFF LABEL USE). THE VALVE COULD NOT BE DEPLOYED AND THEREFORE THE COMMANDER AND VALVE WERE REMOVED. THE SAME VALVE WAS THEN CRIMPED ON A NEW COMMANDER AND SUCCESSFULLY IMPLANTED.
IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TF DELIVERY SYSTEM. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN UNKNOWN EDWARDS TF DELIVERY SYSTEM ARE LISTED BELOW: P110021- RETROFLEX 3 DELIVERY SYSTEM OR ASCENDRA DELIVERY SYSTEM; P130009 - NOVAFLEX+ DELIVERY SYSTEM OR ASCENDRA+ DELIVERY SYSTEM; P140031- EDWARDS COMMANDER¿ DELIVERY SYSTEM. INVESTIGATION OF THIS EVENT IS ONGOING.
AS REPORTED BY OUR AFFILIATES IN (B)(4), PER ARTICLE: "PERCUTANEOUS PULMONARY VALVE IMPLANTATION FOR RECONSTRUCTION OF A PATCH-REPAIRED RIGHT VENTRICULAR OUTFLOW TRACT", BETWEEN MARCH 2007 AND MARCH 2017, 7 PATIENTS RECEIVED A PPVI (PERCUTANEOUS PULMONARY VALVE IMPLANTATION) WITH A SAPIEN¿ VALVE TO REPAIR CONDUIT-FREE, PATCH AUGMENTED RVOT (RIGHT VENTRICULAR OUTFLOW TRACT). IN ONE CASE THE DELIVERY SYSTEM OF A SAPIEN¿ VALVE COULD NOT BE USED DUE TO A DEFECTIVE BALLOON, SO THE ENTIRE SYSTEM HAD TO BE REMOVED AND REPLACED BY A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633106 | UNKNOWN EDWARDS DELIVERY SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9610TF29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |