SAPIEN XT TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2026-13140
- Event Type
- Injury
- Date Received
- March 12, 2026
- Date of Event
- May 1, 2016
- Report Date
- March 27, 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 TYPE OF INVESTIGATION, CORRECTED H6 INVESTIGATION FINDINGS, CORRECTED H6 INVESTIGATION CONCLUSIONS, AND UPDATED H10. THE EVENT REPORTED IS ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. ADDITIONAL ASSESSMENT OF THE FAILURE MODE(S) 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 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, THIS WAS AN OFF-LABEL OPERATION TO IMPLANT THV IN A NATIVE RVOT/PULMONIC POSITION. PER THE 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 WERE REVIEWED FOR SIMILAR INSTRUCTIONS FOR INDICATIONS, WARNINGS, PRECAUTIONS, AND POTENTIAL ADVERSE EVENTS. NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE STRUCTURAL VALVE DETERIORATION (SVD) WAS 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. STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS. SVD 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 THE SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE. 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. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. 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 29MM SAPIEN XT OR SAPIEN 3 VALVE IMPLANTED IN THE PULMONIC POSITION VIA THE FEMORAL OR JUGULAR VEIN DEVELOPED PROSTHETIC VALVE DYSFUNCTION OF UNCERTAIN ETIOLOGY 2 YEARS AND ELEVEN MONTHS POST-IMPLANTATION. A REDO PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639256 | SAPIEN XT TRANSCATHETER HEART VALVE | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED | NPV | EDWARDS LIFESCIENCES | 9300TFX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Unknown | Required Intervention |