SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2025-07407
- Event Type
- Death
- Date Received
- September 9, 2025
- Date of Event
- June 1, 2017
- Report Date
- November 12, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPU
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INCLUDE ADDITIONAL INFORMATION. THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE SEE MANUFACTURER REPORT NUMBERS 2015691-2025-07409, 2015691-2025-07411, 2015691-2025-07414, 2015691-2025-07430, AND 2015691-2025-07432 FOR DETAILS OF THE OTHER EVENTS.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION TO DOCUMENT THE RELATED MANUFACTURER REPORT NUMBERS IN SECTION H10 (RELATED REPORT NUMBERS).
REFERENCE FOR JOURNAL ARTICLE: KHAN JM, BABALIAROS VC, GREENBAUM AB, MCCABE JM, ROGERS T, ENG MH, FOERST JR, YAZDANI S, PAONE G, GLEASON PT, HALABY RN, BRUCE CG, TIAN X, STINE AM, LEDERMAN RJ. 5-YEAR OUTCOMES OF ANTERIOR MITRAL LEAFLET LACERATION TO PREVENT OUTFLOW OBSTRUCTION. JACC CARDIOVASC INTERV. 2024 SEP 23;17(18):2157-2167. THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MIGRATION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER VALVE REPLACEMENT (TVR). ACCORDING TO THE LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE ANNULUS. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE VENTRICLE. THE DEVICE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVES. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR IN THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR MIGRATION (I.E., MINIMAL LEAFLET CALCIFICATION), BALLOON VALVULOPLASTY MAY INDICATE POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THE VALVE MIGRATION EVENT. INVESTIGATION RESULTS SUGGEST PATIENT FACTORS (HYPERTROPHIED AND CALCIFIED SUBVALVULAR STRUCTURES) MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE/PRE-STENT AND THE LANDING ZONE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST-DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE LANDING ZONE, UNEVEN DISTRIBUTION OF CALCIUM ON THE LANDING ZONE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE, AND VALVE UNDER-SIZING. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVES. THE DEVICE TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROPER IMAGING SCREENING REQUIREMENTS, INCLUDING THE USE OF GOOD QUALITY ECHOCARDIOGRAPHY AND/OR COMPUTED TOMOGRAPHY (CT) TO APPROPRIATELY MEASURE THE LANDING ZONE, ASSESS THE CONTENT AND DISTRIBUTION OF CALCIUM, AND OTHER PATIENT ANATOMICAL FACTORS. MULTIPLE IMAGING MODALITIES SHOULD BE CONSIDERED DURING VALVE SIZE SELECTION. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER TRANSCATHETER HEART VALVE ARE ALSO DISCUSSED. THE DEVICE TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING PATIENTS SCREENING AND PROCEDURAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THE PVL EVENT. INVESTIGATION RESULTS SUGGEST PROCEDURAL FACTORS (VALVE MIGRATION) 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 FROM THE JOURNAL ARTICLE "5-YEAR OUTCOMES OF ANTERIOR MITRAL LEAFLET LACERATION TO PREVENT OUTFLOW OBSTRUCTION", A TOTAL OF THIRTY SUBJECTS WERE ENROLLED IN A LAMPOON TRIAL BETWEEN JUNE 2017 AND JUNE 2018. SUBJECTS UNDERWENT EITHER A LAMPOON AND VALVE-IN-MITRAL ANNULAR CALCIFICATION (MAC) PROCEDURE OR A LAMPOON AND VALVE-IN-RING PROCEDURE USING A SAPIEN 3 VALVE. THE FOLLOWING EVENT WAS IDENTIFIED: ONE CASE WHERE THE VALVE HAD MIGRATED ATRIALLY DURING IMPLANTATION, LIKELY FROM HYPERTROPHIED AND CALCIFIED SUBVALVULAR STRUCTURES, RESULTING IN SEVERE PARAVALVULAR LEAK (PVL) AND REQUIRED BAIL-OUT SURGERY. APPROXIMATELY 33 DAYS POST LAMPOON AND TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE, THE PATIENT PASSED AWAY. THE DATE OF DEATH REMAINS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2835290 | SAPIEN 3 TRANSCATHETER HEART VALVE | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED | NPU | EDWARDS LIFESCIENCES | 9600TFX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| R |