SAPIEN XT TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2026-13139
- Event Type
- Injury
- Date Received
- March 12, 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. INVESTIGATION IS ONGOING. 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 FOR CORRECTION AND ADDITIONAL INFORMATION BASED ON THE ENGINEER EVALUATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: ADDITIONAL CODES ADDED TO H6 COMPONENT CODE, ADDITIONAL CODES ADDED TO H6 TYPE OF INVESTIGATION, CORRECTED H6 INVESTIGATION FINDINGS, CORRECTED H6 INVESTIGATION CONCLUSIONS, AND UPDATED H10. THE EVENTS REPORTED ARE ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. IT SHOULD BE NOTED THAT THE TRANSCATHETER HEART VALVE (THV) WAS IMPLANTED IN NATIVE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AT THE PULMONIC POSITION. THE SAPIEN XT THV (WITH NOVAFLEX+ DELIVERY SYSTEM) AND THE SAPIEN 3 THV (WITH COMMANDER DELIVERY SYSTEM) WERE INDICATED FOR A DYSFUNCTIONAL, PREVIOUSLY REPAIRED OR REPLACED NON-COMPLIANT RIGHT VENTRICULAR OUTFLOW TRACT/PULMONARY VALVE (RVOT/PV) OR PREVIOUSLY IMPLANTED VALVE IN THE PULMONIC POSITION REPLACEMENT ONLY. THEREFORE, IT WAS OFF LABEL OPERATION TO IMPLANT THV IN A NATIVE RVOT/PULMONIC POSITION. PER ARTICLE, THE IMPLANTS OCCURRED BETWEEN 2016 AND 2022. HOWEVER, THE EXACT IMPLANT DATE, VALVE MODEL AND USED OF DELIVERY SYSTEM WERE UNKNOWN FOR THIS CASE. SO, THE EXACT IFU WAS UNABLE TO BE DETERMINED. HOWEVER, ALL THE IFUS HAD THE FOLLOWING SIMILAR INSTRUCTIONS FOR INDICATIONS, WARNINGS, PRECAUTIONS, AND POTENTIAL ADVERSE EVENTS. THE INSTRUCTIONS FOR USE (IFU), AND TRAINING MANUALS HAVE BEEN REVIEWED. NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED LEAFLET MOTION RESTRICTION, DEVICE STENOSIS, AND CENTRAL REGURGITATION WERE CONFIRMED BASED ON AVAILABLE INFORMATION TO DATE. A REVIEW OF COMPLAINT HISTORY DID NOT INDICATE ANY MANUFACTURING NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DURING THE MANUFACTURING PROCESS, ALL SAPIEN XT/3 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 EVENT. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. 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. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. 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. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.
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 VIA THE FEMORAL OR JUGULAR VEIN DEVELOPED PROSTHETIC VALVE DYSFUNCTION DUE TO FROZEN LEAFLETS WITH MIXED MECHANISMS OF PULMONARY STENOSIS AND PULMONARY REGURGITATION APPROXIMATELY 4 AND A HALF YEARS POST-IMPLANTATION. A REDO PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222794 | SAPIEN XT TRANSCATHETER HEART VALVE | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED | NPV | EDWARDS LIFESCIENCES | 9300TFX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Unknown | Required Intervention |