SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2025-07430
- Event Type
- Injury
- Date Received
- September 9, 2025
- Date of Event
- June 1, 2017
- Report Date
- September 11, 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
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. THE INVESTIGATION IS ONGOING.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION, TO INCLUDE ADDITIONAL INFORMATION AND DOCUMENT THE RELATED MANUFACTURER REPORT NUMBERS AND TO INCLUDE ADDITIONAL INFORMATION FROM THE INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED/UPDATED: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10 (RELATED REPORT NUMBERS), AND H11 (ADDITIONAL NARRATIVE/DATA). THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE SEE MANUFACTURER REPORT NUMBERS 2015691-2025-07407, 2015691-2025-07409, 2015691-2025-07411, 2015691-2025-07414, AND 2015691-2025-07432 FOR DETAILS OF THE OTHER EVENTS. PER THE INSTRUCTIONS FOR USE (IFU), LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (THV). LVOT OBSTRUCTION IN PATIENTS WHO UNDERGO TRANSCATHETER VALVE REPLACEMENT IS A WELL-RECOGNIZED POSTOPERATIVE COMPLICATION. IN MOST CASES OF POSTOPERATIVE LVOT OBSTRUCTION, THE OBSTRUCTION RESULTS FROM THE PROTRUSION OF THE VALVE INTO THE LVOT OR FROM ABNORMAL SUBVALVULAR POSITIONING OF THE VALVE. ADDITIONALLY, LVOT OBSTRUCTION MAY OCCUR POSTOPERATIVELY IF THERE IS A NARROWED MITRAL-AORTIC ANGLE, OR DUE TO A THICKENED INTERVENTRICULAR SEPTUM. OTHER POSSIBLE CAUSES INCLUDE A HYPER CONTRACTILE LEFT VENTRICLE OR ATRIAL FIBRILLATION. OBSTRUCTION OF THE LEFT VENTRICULAR OUTFLOW TRACT CAN ALSO BE CAUSED BY PATIENT FACTORS (ANTERIOR MITRAL LEAFLET PROTRUDING INTO THE LVOT) OR PROCEDURAL FACTORS (POSITIONING OF THE VALVE WITHIN THE ANNULUS). INACCURATE DEPLOYMENT IS GENERALLY A RESULT OF USE ERROR OR A COMBINATION OF PATIENT AND PROCEDURAL FACTORS. IN SOME CASES, THIS WOULD NOT CAUSE HEMODYNAMIC COMPROMISE BUT MAY RESULT IN AN INCREASE IN THE SUBVALVULAR LVOT GRADIENT. IN OTHER CASES, LVOT OBSTRUCTION COULD RESULT IN CLINICALLY SIGNIFICANT HEMODYNAMIC COMPROMISE THAT MAY REQUIRE ADDITIONAL INTERVENTION TO CORRECT. IN THIS JOURNAL ARTICLE, THERE WERE THREE CASES OF LVOT OBSTRUCTION THAT REQUIRED ALCOHOL SEPTAL ABLATION IMMEDIATELY AFTER THE LAMPOON AND TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE DUE TO THE PATIENT'S ANATOMY. THE EDWARDS THV PATIENT SCREENING MANUAL ADVISES THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE NATIVE VALVE AND ROOT, TAKING INTO CONSIDERATION THE DEGREE AND DISTRIBUTION OF NATIVE LEAFLET CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS 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 TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. THE CORRECT SIZING, ALIGNMENT, AND POSITIONING OF THE DEVICE ARE EMPHASIZED AS KEY FACTORS TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, INVESTIGATION RESULTS SUGGEST PATIENT FACTORS (SKIRT NEO-LVOTS LESS THAN 150 MM2) 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: THREE CASES OF LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OBSTRUCTION THAT REQUIRED ALCOHOL SEPTAL ABLATION IMMEDIATELY AFTER THE LAMPOON AND TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) PROCEDURE DUE TO THE SKIRT NEO-LVOTS BEING LESS THAN 150 MM2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2500504 | SAPIEN 3 TRANSCATHETER HEART VALVE | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED | NPU | EDWARDS LIFESCIENCES | 9600TFX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |