SAPIEN XT TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2026-13134
- Event Type
- Injury
- Date Received
- March 11, 2026
- Date of Event
- May 1, 2016
- Report Date
- April 1, 2026
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM MAY 2016 AND OCTOBER 2022. THEREFORE, (B)(6) 2016, WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THE SAPIEN XT AND SAPIEN 3 WERE IDENTIFIED IN THE LITERATURE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBER ASSOCIATED WITH AN EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS P130009. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE P140031 AND P200015. 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),PHARMACOLOGICAL THERAPIES THAT QUICKLY INCREASE HEMOGLOBIN LEVELS, 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. WITH THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF THE THROMBUS IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. 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. LITERATURE REFERENCE: BELAHNECH, Y., MARTI-AGUASCA, G., DOS-SUBIRA, L., BETRIAN-BLASCO, P., GARCIA DEL BLANCO, B., CALVO-BARCELO, M., ... & FERREIRA-GONZALEZ, I. (2025). MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT. SCIENTIFIC REPORTS, 15(1), 3977.
A SUPPLEMENTAL MDR IS BEING SUBMITTED TO UPDATE THE FOLLOWING SECTION: H10 RELATED REPORT NUMBERS.
THROUGH REVIEW OF MEDICAL ARTICLE "MID-TERM OUTCOMES OF PERCUTANEOUS PULMONARY VALVE REPLACEMENT WITH EDWARDS-SAPIEN BIOPROSTHESIS IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT", BY CORRESPONDING AUTHOR DR. YASSIN BELAHNECH, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A 20, 23, 26, OR 29 MM SAPIEN XT OR SAPIEN 3 VALVE IMPLANTED IN THE PULMONIC POSITION (NON-NATIVE RIGHT VENTRICULAR OUTFLOW TRACT) VIA THE FEMORAL OR JUGULAR VEIN DEVELOPED PROSTHETIC VALVE DYSFUNCTION DUE TO THROMBOSIS 9.7 MONTHS POST-IMPLANTATION, RESULTING IN PULMONARY STENOSIS AND REQUIRING A REDO PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636464 | SAPIEN XT TRANSCATHETER HEART VALVE | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED | NPV | EDWARDS LIFESCIENCES | 9300TFX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Unknown | Required Intervention |