EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2018-02867
- Event Type
- Injury
- Date Received
- July 18, 2018
- Date of Event
- June 20, 2018
- Report Date
- June 25, 2018
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. THE SAPIEN 3 VALVE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. NO PHOTOGRAPHS, VIDEO OR IMAGERY WAS PROVIDED FOR EVALUATION. REVIEW OF THE LOT HISTORY DID NOT REVEAL ANY OTHER COMPLAINTS RELATED TO ¿VALVE ¿ PV LEAK¿. THE LOT NUMBER FOR THE VALVE COMPLAINTS REFERENCE THE VALVE SERIAL NUMBER ONLY; THEREFORE, THE REVIEW WAS PERFORMED FOR VALVE SERIAL NUMBERS 5925989 THROUGH 5926003, VERIFYING THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH EACH SERIAL NUMBER. REVIEW OF THE COMPLAINT HISTORY FOR THE SAPIEN 3 VALVE (ALL SIZES) FROM JULY 2017 TO JUNE 2018 REVEALED NO OTHER COMPLAINTS FOR ¿VALVE ¿ REGURGITATION ¿ PV LEAK¿. A REVIEW OF THE COMPLAINT HISTORY REVEALED THAT THE OCCURRENCE RATE DID NOT EXCEED THE JANUARY 2018 CONTROL LIMITS FOR TREND CATEGORY ¿REGURGITATION¿. REVIEW OF THE DEVICE PREPPING MANUAL AND TRAINING MANUAL FOR THE COMMANDER DELIVERY SYSTEM DID NOT IDENTIFY ANY IFU/TRAINING DEFICIENCIES. 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. A REVIEW OF THE WORK ORDERS WAS PERFORMED FOR THE COMPONENTS MOST RELEVANT TO THE REPORTED EVENT. THE WORK ORDERS DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DURING THE MANUFACTURING PROCESS, THE SAPIEN 3 VALVE COMPONENTS UNDERGO 100% VISUAL INSPECTIONS BY MANUFACTURING AND QUALITY. THE FRAMES UNDERGO MULTIPLE 100% INSPECTIONS FOR PHYSICAL DEFECTS AND ARE ALSO 100% DIMENSIONALLY INSPECTED. IN ADDITIONAL TO THESE INSPECTIONS, SAMPLES FROM EACH ANNEALING LOT ARE TESTED TO DETERMINE ULTIMATE TENSILE STRENGTH AND PERCENT ELONGATION AT FRACTURE. VALVE SKIRT COMPONENTS UNDERGO 100% VISUALLY AND DIMENSIONALLY INSPECTIONS. THE VALVE ALSO UNDERGOES MULTIPLE 100% INSPECTIONS DURING THE VALVE ASSEMBLY PROCESS. PRIOR TO FINAL PACKAGING, THE VALVE UNDERGOES 100% VISUAL INSPECTION TO ENSURE NO DAMAGE TO THE VALVE FROM HANDLING HAS OCCURRED. THESE INSPECTIONS MAKE IT UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. IN THIS CASE, THE WORSENING PVL WAS NOT ABLE TO BE CONFIRMED SINCE NO PHOTOGRAPHS OR CASE IMAGERY WAS PROVIDED. PER THE PHYSICIAN, THE WORSENING OF PVL ON POD20 WAS POSSIBLY DUE TO RECOILING OF THE SAPIEN 3 VALVE. THE POTENTIAL ROOT CAUSES OF RECOIL COULD BE RELATED TO INCORRECT GEOMETRIES AND/OR INCORRECT MATERIAL PROPERTIES OF THE FRAME. HOWEVER, WITHOUT DEVICE RETURN, ADDITIONAL VISUAL (E.G. X-RAY & SEM ANALYSIS), DIMENSIONAL (E.G. THICKNESS OF THE FRAME), CHEMISTRY (E.G. FTIR ANALYSIS) AND/OR MECHANICAL TESTING (E.G. ULTIMATE TENSILE STRENGTH, PERCENTAGE ELONGATION & AVERAGE GRAIN SIZE) WERE UNABLE TO BE PERFORMED. ADDITIONALLY, WITHOUT PROCEDURAL IMAGERY RETURNED FOR EVALUATION, THE OVERALL GEOMETRY AND/OR POSITION OF THE IMPLANTED VALVE IMMEDIATELY POST OPERATION, AFTER SYSTEM WITHDRAWAL, AND POST DILATION COULD NOT BE COMPARED. THEREFORE, IT COULD NOT BE DETERMINED IF ANY MANUFACTURING NON-CONFORMITIES CONTRIBUTED TO THE COMPLAINT. HOWEVER, A REVIEW OF THE DHR, LOT HISTORY, COMPLAINT HISTORY, AND MANUFACTURING MITIGATIONS REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. RECORDS INDICATE THAT ALL FRAMES RELEASED FOR PRODUCTION BUILT HAD 100% PASSED FOR BOTH VISUAL AND DIMENSIONAL INSPECTIONS DURING RECEIVING INSPECTIONS. ADDITIONALLY, ALL FRAME LOTS HAD PASSED THE MECHANICAL TESTS BASED ON THE SAMPLING PLAN. AS SUCH, IT IS UNLIKELY THAT THE COMPLAINT WAS A RESULT OF A MANUFACTURING NONCONFORMANCE. ALTHOUGH A DEFINITE ROOT CAUSE OF THE WORSENING PVL ON POD20 CANNOT BE DETERMINED, AVAILABLE INFORMATION INDICATES IN ADDITION TO THE PROCEDURE ITSELF, PATIENT FACTORS (VALVULAR CALCIFICATION, STJ CALCIFICATION) MAY HAVE CONTRIBUTED TO THE WORSENING PVL AND SUBSEQUENT RE-DILATION OF THE 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.
CORRECTED DATA: F10, H6. REFERENCE (B)(4).
AS REPORTED IN AN ARTICLE, ¿A CLINICAL CASE OF SUCCESSFUL PERCUTANEOUS BALLOON AORTIC VALVULOPLASTY FOR WORSENING PARAVALVULAR LEAKAGE DUE TO RECOIL OF SAPIEN 3¿, A 23MM SAPIEN 3 VALVE WAS DEPLOYED WITH NOMINAL VOLUME. TWENTY DAYS POST VALVE DEPLOYMENT, WORSENING PARAVALVULAR LEAK (PVL) WAS OBSERVED. THE DIAMETER OF THE IMPLANTED VALVE SHORTENED AT 3 SECTIONS: FROM 21.7MM TO 20.72MM AT THE OUTFLOW SIDE, FROM 20.12MM TO 19.21MM AT THE MEDIAN, AND FROM 21.57MM TO 21.05MM AT THE INFLOW SIDE. ADDITIONAL BAV WAS PERFORMED FOR THE RECOIL WITH 2 ML MORE THAN NOMINAL VOLUME AND THE PVL WAS REDUCED. THE VALVE ¿RECOIL¿ WAS ONE OF THE LIKELY MECHANISMS FOR THE WORSENING PVL. REFERENCE FOR ARTICLE: TAKAYOSHI TOBA, ET AL. (2019). A CLINICAL CASE OF SUCCESSFUL PERCUTANEOUS BALLOON AORTIC VALVULOPLASTY FOR WORSENING PARAVALVULAR LEAKAGE DUE TO RECOIL OF SAPIEN 3. 2019 PCR TOKYO VALVES. RETRIEVED FROM: HTTPS://WWW.PCRONLINE.COM/COURSES/PCR-TOKYO-VALVES.
AS REPORTED IN AN ARTICLE, ¿A CLINICAL CASE OF SUCCESSFUL PERCUTANEOUS BALLOON AORTIC VALVULOPLASTY FOR WORSENING PARAVALVULAR LEAKAGE DUE TO RECOIL OF SAPIEN 3¿, A 23MM SAPIEN 3 VALVE WAS DEPLOYED WITH NOMINAL VOLUME. TWENTY DAYS POST VALVE DEPLOYMENT, WORSENING PARAVALVULAR LEAK (PVL) WAS OBSERVED. THE DIAMETER OF THE IMPLANTED VALVE SHORTENED AT 3 SECTIONS: FROM 21.7MM TO 20.72MM AT THE OUTFLOW SIDE, FROM 20.12MM TO 19.21MM AT THE MEDIAN, AND FROM 21.57MM TO 21.05MM AT THE INFLOW SIDE. ADDITIONAL BAV WAS PERFORMED FOR THE RECOIL WITH 2 ML MORE THAN NOMINAL VOLUME AND THE PVL WAS REDUCED. THE VALVE ¿RECOIL¿ WAS ONE OF THE LIKELY MECHANISMS FOR THE WORSENING PVL. REFERENCE FOR ARTICLE: TAKAYOSHI TOBA, ET AL. (2019). A CLINICAL CASE OF SUCCESSFUL PERCUTANEOUS BALLOON AORTIC VALVULOPLASTY FOR WORSENING PARAVALVULAR LEAKAGE DUE TO RECOIL OF SAPIEN 3. 2019 PCR TOKYO VALVES. RETRIEVED FROM: HTTPS://WWW.PCRONLINE.COM/COURSES/PCR-TOKYO-VALVES.
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.
AS REPORTED BY OUR AFFILIATE IN (B)(6), DURING A TRANSFEMORAL TAVR PROCEDURE, A 23 MM SAPIEN 3 VALVE WAS DEPLOYED IN A 50:50 AORTIC/VENTRICULAR (A/V) POSITION AS INTENDED. MILD PARAVALVULAR LEAK (PVL) REMAINED. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. ON POSTOPERATIVE DAY (POD) 20, TTE SHOWED AN INCREASED PVL. A DETAILED EXAMINATION, INCLUDING CT, WAS PERFORMED. RE-DILATION OF THE VALVE WITH A 23 MM BALLOON WAS PERFORMED SINCE THE INCREASED PVL WAS SUSPECTED TO POSSIBLY BE DUE TO VALVE RECOIL. PROPER VALVE EXPANSION WAS ACHIEVED WITH DECREASED PVL. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING WELL. THE VALVE REMAINS IMPLANTED IN THE PATIENT. THE NATIVE ANNULAR VALVE AREA MEASURED 380 MM2. MILD AORTIC VALVE AND ANNULAR CALCIFICATION WAS REPORTED. A NARROW SINOTUBULAR JUNCTION (STJ) DIAMETER OF 20 MM X 20 MM WAS REPORTED. STJ CALCIFICATION WAS REPORTED AS COVERING 75% OF THE PERIMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540252 | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9600TFX23J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |