EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2025-00929
- Event Type
- Injury
- Date Received
- February 11, 2025
- Date of Event
- March 1, 2024
- Report Date
- February 11, 2025
- Manufacturer
- EDWARDS LIFESCIENCES LLC
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PER THE INSTRUCTIONS FOR USE (IFU), VALVE THROMBOSIS IS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE TRANSCATHETER HEART VALVES (THV). USE OF THE SAPIEN TRANSCATHETER HEART VALVES (ALL MODELS) IS CONTRAINDICATED IN PATIENTS WHO CANNOT TOLERATE AN ANTICOAGULATION/ANTIPLATELET REGIMEN. IN ADDITION, IT WARNS THAT VALVE RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT/ANTIPLATELET THERAPY, EXCEPT WHEN CONTRAINDICATED, AS DETERMINED BY THEIR PHYSICIAN. THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. POTENTIAL PATIENT RISK FACTORS SUCH AS ATRIAL FIBRILLATION, SYSTEMIC DISEASE (E.G., SYSTEMIC LUPUS ERYTHEMATOSUS, INFLAMMATION, AND DAMAGE TO VARIOUS BODY TISSUES, INCLUDING JOINTS, SKIN, KIDNEYS, HEART, LUNGS, BLOOD VESSELS, AND BRAIN), THE VALVULAR DISEASE ITSELF, AND REDUCED CARDIAC EJECTION FRACTION CAN CONTRIBUTE TO INCREASED RISK OF THROMBUS/THROMBOSIS. SUB-OPTIMAL ANTICOAGULATION DURING THE PROCEDURE AND UNDERLYING PATIENT CONDITIONS CAN ALSO RESULT IN INCREASED THROMBOGENICITY. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS PREPARATION, ASPIRATION, AND FLUSHING OF THE DEVICES TO PREVENT AND/OR REMOVE CLOT(S). SHORT-TERM ANTICOAGULATION THERAPY MAY ALSO BE NECESSARY AFTER VALVE REPAIR, ANTICOAGULATION IS PRESCRIBED PER INSTITUTIONAL GUIDELINES. INTRA-PROCEDURAL INTRA-CARDIAC THROMBUS AND POST-PROCEDURE OR LATE VALVE THROMBOSIS ARE COMPLEX PROCESSES TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE WHICH ARE HIGHLY VARIABLE AMONG PATIENTS. IT IS THE NATURAL TENDENCY OF THE BODY TO FORM A CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE AND A DEFINITIVE ROOT CAUSE CANNOT ALWAYS BE CONFIRMED. THE DEVICE TRAINING MANUALS INSTRUCT THE OPERATOR TO CONSIDER ALL PROCEDURAL AND ANATOMICAL FACTORS. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE DEVICE SYSTEM. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY IN CONJUNCTION WITH ECHOCARDIOGRAPHY FOR OPTIMAL VISUALIZATION DURING POSITIONING AND DEPLOYMENT AND CAUTIONS INCLUDE THE MAINTENANCE OF THE PATIENT'S ANTICOAGULATION STATUS (ACT AT >250 SECONDS) DURING THE PROCEDURE IN ORDER TO PREVENT THROMBOSIS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PATIENT FACTORS (GRADE 5 CHRONIC KIDNEY DISEASE, HYPERTENSION) MAY HAVE CAUSED OR CONTRIBUTED TO THIS 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 THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
AS REPORTED THROUGH THE ARTICLE "HYPOXIA-INDUCIBLE FACTOR PROLYL HYDROXYLASE INHIBITOR-INDUCED THROMBOSIS LEADING TO TRANSCATHETER AORTIC VALVE DYSFUNCTION: A CASE REPORT", APPROXIMATELY ONE MONTH FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), DYSFUNCTION OF THE 23 MM SAPIEN 3 ULTRA RESILIA VALVE OCCURRED, DUE TO A RAPIDLY DEVELOPING DRUG-INDUCED VALVE THROMBOSIS. THE PATIENT UNDERWENT TAVR WITH 23 MM SAPIEN 3 ULTRA RESILIA (S3UR) FOR SEVERE AORTIC STENOSIS. ONE MONTH LATER, THE PATIENT DEVELOPED ACUTE HEART FAILURE WITH SHORTNESS OF BREATH. AS THE PROGRESSION OF ANEMIA DUE TO RENAL ANEMIA SEEMED TO CAUSE ACUTE HEART FAILURE EXACERBATION, ORAL HYPOXIA-INDUCIBLE FACTOR PROLYL HYDROXYLASE (HIF-PH) INHIBITOR WAS STARTED. AFTER 2 WEEKS, THE PATIENT REDEVELOPED SHORTNESS OF BREATH. THE PATIENT WAS ADMITTED. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED THAT THE MEAN AORTIC VALVE PRESSURE GRADIENT INCREASED FROM 9 TO 54 MMHG, AND THE AORTIC VALVE AREA DECREASED FROM 1.93 TO 0.86 CM2. BLOOD WORK REVEALED A MARKEDLY ELEVATED HEMOGLOBIN LEVEL FROM 8.0 TO 13.2 G/DL, AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED MARKEDLY DECREASED LEFT CORONARY AND NON-CORONARY CUSP MOBILITY. THE MEDICAL TEAM DIAGNOSED THAT THE RAPID INCREASE IN THE HEMOGLOBIN LEVEL CAUSED BY THE HIF-PH INHIBITOR WAS RELATED TO VALVE THROMBOSIS AND BIOPROSTHETIC DYSFUNCTION OF THE TRANSCATHETER AORTIC VALVE. THE HIF-PH INHIBITOR WAS DISCONTINUED, AND ANTICOAGULATION THERAPY WAS STARTED. TRANSTHORACIC ECHOCARDIOGRAPHY AT 16 DAYS LATER REVEALED THAT THE LEFT AND NON-CORONARY CUSP MOBILITY IMPROVED, THE MEAN AORTIC VALVE PRESSURE GRADIENT IMPROVED BY 15 MMHG, AND THE SUBJECTIVE SYMPTOMS RESOLVED. AS THE THROMBOGENICITY HAD RESOLVED AND THE BLEEDING RISK WAS HIGH, WARFARIN WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO A SINGLE ANTIPLATELET AGENT 7 DAYS AFTER THE LAST TTE. THE PATIENT PRESENTED FOR A 1-MONTH FOLLOW-UP AFTER DISCHARGE WITH CONTINUED IMPROVEMENT IN SYMPTOMS. SHE WAS TREATED WITH A SINGLE ANTIPLATELET AGENT WITHOUT RESTARTING ANTICOAGULATION, AND THE MEAN AORTIC VALVE PRESSURE GRADIENT REMAINED AT 16 MMHG WITHOUT WORSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1657778 | EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES LLC | 9755RSL23J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Female | Hospitalization |