EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
Report
- Report Number
- 2015691-2024-09586
- Event Type
- Injury
- Date Received
- December 13, 2024
- Date of Event
- March 4, 2024
- Report Date
- January 20, 2025
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE REPORTABILITY OF THE EVENT PREVIOUSLY REPORTED. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD A BASE LINE ATRIAL FIBRILLATION. THE SAPIEN 3 ULTRA VALVE WAS IMPLANTED FIRST. NO CONDUCTIONS ANOMALIES WERE DETECTED DURING THE TAVR PROCEDURE AND THE RHYTHM AFTER IMPLANTATION WAS ATRIAL FIBRILLATION, SAME AS BEFORE THE PROCEDURE. DURING THE IMPLANTATION OF THE EVOQUE VALVE, THE PATIENT HAD A PAROXYMAL COMPLETE AV BLOCK REQUIRING A TEMPORARY LEAD. AFTER THE PROCEDURE, DURING THE SAME DAY A PERMANENT PACEMAKER WAS IMPLANTED. THE HEART BLOCK AND PPPM WAS DETERMINED TO BE PREVIOUSLY REPORTED AND CAPTURED UNDER MEDWATCH #201569-2024-09737. AT THE TIME OF THIS REPORT, THE INFORMATION AVAILABLE DOES NOT SUGGEST THE SAPIEN 3 ULTRA MALFUNCTIONED, OR THAT THE USE OR MISS-USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO ALLEGATION OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, LABELING EFFECTIVENESS, OR PERFORMANCE OF THIS EDWARD SAPIEN 3 ULTRA VALVE, THEREFORE THE EVENT IS A DUPLICATE AND IS NO LONGER CONSIDERED FDA REPORTABLE.
E1 PHONE NUMBER (B)(6) PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS WHICH MAY OR MAY NOT REQUIRE A PERMANENT PACEMAKER IMPLANTATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY EXPLAIN THESE COMPLICATIONS OF THE TVR PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN EW CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS, CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PREOPERATIVE COMORBID STATUS, THE DEGREE, AND BULKINESS OF ANNULAR CALCIFICATION, INTERVENTRICULAR SEPTAL THICKNESS, HISTORY OF ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AORTIC VALVE REPLACEMENT (AVR), WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND SUTURE PLACEMENT IN THE PROXIMITY OF THE ATRIOVENTRICULAR (AV) NODE OR THE BUNDLES, THE TRANSCATHETER HEART VALVE MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THE CAUSE OF THE HEART BLOCK COULD NOT BE DETERMINED. 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 AT THIS TIME
A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION. SECTION B5, D4, G3, G6, H2, H4, H10 HAVE BEEN UPDATED.
AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN SWITZERLAND, REGARDING AN IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION. THE IMPLANTATION WAS PERFORMED DURING THE SAME PROCEDURE OF EVOQUE VALVE IMPLANTATION IN TRICUSPID POSITION. DURING THE IMPLANTATION OF THE EVOQUE VALVE, THE PATIENT REQUIRED A TEMPORARY LEAD. THE SEQUENCE OF THE IMPLANTATION PROCEDURE (VALVE IMPLANTED FIRST) WAS STILL UNKNOWN. SAME DAY OF THE PROCEDURE, THE PATIENT HAD A COMPLETE AV BLOCK AND A PERMANENT PACEMAKER WAS IMPLANTED (VVI WITH RV LEAD IN LBBAP POSITION).
ADDITIONAL INFORMATION: THE IMPLANTATION WAS PERFORMED DURING THE SAME PROCEDURE OF EVOQUE VALVE IMPLANTATION IN TRICUSPID POSITION. THE SAPIEN 3 ULTRA VALVE WAS IMPLANTED FIRST. NO CONDUCTIONS ANOMALIES WERE DETECTED DURING THE TAVR PROCEDURE AND THE RHYTHM AFTER IMPLANTATION WAS ATRIAL FIBRILLATION, SAME AS BEFORE THE PROCEDURE. DURING THE IMPLANTATION OF THE EVOQUE VALVE, THE PATIENT HAD A PAROXYMAL COMPLETE AV BLOCK REQUIRING A TEMPORARY LEAD. AFTER THE PROCEDURE, DURING THE SAME DAY A PERMANENT PACEMAKER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1857687 | EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9750TFX26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | Required Intervention |