EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-00734
- Event Type
- Injury
- Date Received
- February 1, 2024
- Date of Event
- December 4, 2023
- Report Date
- March 12, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- UDI-DI
- 00690103201338
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS ONGOING. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.
A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND ADDITIONAL INFORMATION BASED ON MEDICAL RECORDS RECEIVED. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: B3, B7, CORRECTED H6 HEALTH EFFECT-CLINICAL CODE, ADDITIONAL CODE ADDED TO H6 DEVICE CODE(S), AND ADDITIONAL CODE ADDED TO H6 TYPE OF INVESTIGATION. PER THE MEDICAL RECORDS RECEIVED, TTE COMPLETED 1 YEAR AND 6 MONTHS POST-IMPLANT REVEALED THE VALVE HAD MILD AORTIC REGURGITATION AND APPEARED TO FUNCTION ABNORMALLY WITH STENOSIS. AV MEAN GRADIENT WAS 42MMHG AND AV AREA CONT EQ VTI 0.7 CM2. THE PATIENT HAD BEEN ADMITTED TO THE EMERGENCY DEPARTMENT WITH PROGRESSIVE CHEST DISCOMFORT AS WELL AS SHORTNESS OF BREATH APPROXIMATELY 1 WEEK PRIOR TO THE VALVE IN VALVE PROCEDURE. INVESTIGATION IS ONGOING.
THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. IMAGERY WAS PROVIDED, AND THE FOLLOWING WAS OBSERVED: VALVE WAS UNDER EXPANDED WITH BIG OUTFLOW (TOP AREA = 551.3 MM2) AND SMALL INFLOW (INFLOW AREA = 420.1 MM2). INCIDENT VALVE WAS DEPLOYED IN A PRE-EXISTING SURGICAL VALVE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. A REVIEW OF THE LOT HISTORY REVEALED NO OTHER SIMILAR RETURNED COMPLAINTS FOR THE TREND CATEGORIES. THE INSTRUCTIONS FOR USE/TRAINING MANUALS WERE REVIEWED FOR GUIDANCE/INSTRUCTION INVOLVING THE VALVE USAGE. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND 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 VALVE STENOSIS AND CENTRAL REGURGITATION ARE CONFIRMED BASED ON THE MEDICAL REPORT. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 ULTRA VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE COMPLAINT EVENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIA-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SHORTNESS OF BREATH AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH OR IN RARE CASES, A NON-FUNCTIONING LEAFLET. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. STENOSIS OF AN IMPLANTED VALVE MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION (SVD). THIS TERM REFERS TO CHANGES INTRINSIC TO THE VALVE, AND CAN INCLUDE FAILURE MODES SUCH AS WEAR, CALCIFICATION, LEAFLET TEAR, STENT CREEP, LEAFLET DISRUPTION, OR LEAFLET RETRACTION. SVD MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IT CAN CAUSE THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE. DEPENDING ON SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. IN THIS CASE, THE PATIENT HAD MEDICAL HISTORY OF CORONARY ARTERIOSCLEROSIS AND HYPERLIPIDEMIA. CORONARY ARTERIOSCLEROSIS CAN LEAD TO ATHEROSCLEROSIS, WHICH IS THE BUILDUP OF CALCIFICATION, PLAQUE, OR FATTY MATERIAL ON THE VALVE OVER TIME. THESE DEPOSITS OFTEN COME WITH AGE AND MAKE THE VALVE TISSUE STIFF, NARROW, AND UNYIELDING WHICH CAN CONTRIBUTE TO STENOSIS. IN ADDITION, HYPERLIPIDEMIA IS ALSO A RISK FACTOR DUE TO ELEVATED CHOLESTEROL LEVELS BEING IMPLICATED IN THE VASCULAR CALCIFICATION PROCESS. TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE OF STRUCTURAL VALVE DETERIORATION (SVD), WHICH CAN MANIFEST IN THE FORM OF STENOSIS. PER IMAGING EVALUATION, THE INCIDENT VALVE WAS UNDER EXPANDED. AN UNDER EXPANDED VALVE COULD REDUCE EFFECTIVE ORIFICE AREA (EOA) OF VALVE, AND IT CAN IMPACT VALVE FUNCTIONALITY AS BLOOD FLOW ACROSS THE VALVE WOULD BE OBSTRUCTED, RESULTING IN STENOSIS. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CORONARY ARTERIOSCLEROSIS, HYPERLIPIDEMIA) AND/OR PROCEDURAL FACTORS (UNDER EXPANDED VALVE) MAY HAVE CONTRIBUTED TO THE VALVE STENOSIS. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (THV) PROCEDURE. CENTRAL REGURGITATION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO SEVERAL ISSUES, INCLUDING PATIENT-RELATED FACTORS, STRUCTURAL VALVE DETERIORATION (E.G. CALCIFICATION, LEAFLET THICKENING), AND/OR NONSTRUCTURAL DYSFUNCTION (FIBROSIS, PANNUS FORMATION). IN THIS CASE, THE PATIENT HAD STENOSIS, WHICH CAN AFFECT THE PROPER COAPTATION OF THE THV LEAFLETS, RESULTING IN CENTRAL REGURGITATION. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (STENOSIS) MAY HAVE CONTRIBUTED TO THE CENTRAL REGURGITATION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO IFU/LABELING/TRAINING MANUAL INADEQUACIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME.
AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 1 YEAR AND 7 MONTHS POST IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE WITHIN A PREEXISTING SURGICAL VALVE IN THE AORTIC POSITION, THE VALVE IS FAILING DUE TO CENTRAL AORTIC INSUFFICIENCY. THE PHYSICIAN STATED THEY BELIEVE THE VALVE FAILED EARLY. THE CASE IMAGERY WAS REVIEWED BY AN EDWARDS LIFESCIENCES PROCTOR, WHO STATED THE REASON FOR THE VALVE FAILURE WAS POSSIBLY DUE TO UNDER-EXPANSION OF THE VALVE. THE TEAM PRE-DILATED THE 26MM SAPIEN 3 ULTRA VALVE WITH A 24MM NON-EW BALLOON, AND THEN IMPLANTED A 23MM SAPIEN 3 ULTRA VALVE WITH AN ADDITIONAL 2ML IN THE COMMANDER DELIVERY SYSTEM BALLOON. THE AORTIC INSUFFICIENCY WAS RESOLVED. THE PATIENT WAS IN STABLE CONDITION AND SENT TO RECOVERY WITHOUT ANY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256437 | EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750TFX26A | 00690103201338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Required Intervention |