EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2023-14509
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- May 23, 2023
- Report Date
- August 15, 2023
- Manufacturer
- EDWARDS LFESCIENCES
- Product Code
- NPT
- UDI-DI
- 00690103194357
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR CORRECTION AND ADDITIONAL INFORMATION FROM MEDICAL RECORD REVIEW. THE FOLLOWING SECTION OF THIS REPORT HAS BEEN UPDATED: B.4, B.5, G.3, G,6, AND H.2. THE FOLLOWING SECTIONS OF THIS REPORT HAS BEEN CORRECTED: H.6 DEVICE CODE (ADDED 1457). THE INVESTIGATION IS ONGOING.
SUPPLEMENTAL MDR IS BEING SUBMITTED FOR ADDITIONAL INFORMATION FROM A PRODUCT INVESTIGATION AND INFORMATION PROVIDED BY THE SITE. THE FOLLOWING SECTIONS OF THIS REPORT HAS BEEN UPDATED: B4, B5, D6, G3, G6, H2, AND H6. THE COMPLAINTS FOR ''POST-IMPLANTATION - CENTRAL REGURGITATION'' AND ''POST-IMPLANTATION - PARAVALVULAR LEAK'' WERE CONFIRMED BASED ON MEDICAL RECORD. THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. PER REVIEW, NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 THV VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% FUNCTIONALLY 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. AS REPORTED, ''A TTE PERFORMED APPROXIMATELY 5 YEARS AND 3 MONTHS POST TAVR PROCEDURE SHOWED MODERATE TO SEVERE AORTIC REGURGITATION (PARAVALVULAR LEAK) WAS PRESENT. THERE WERE 2 PARAVALVULAR JETS PRESENT, AT THE 2-3 O'CLOCK POSITION AND AT THE 9-10 O'CLOCK POSITION ON SAX VIEWS. ADDITIONALLY, THERE IS MILD INTRAVALVULAR REGURGITATION.'' PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE THV PROCEDURE. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO SEVERAL ISSUES INCLUDING PATIENT-RELATED FACTORS, STRUCTURAL VALVE DETERIORATION, OR NON-STRUCTURAL DYSFUNCTION (E.G., PANNUS GROWTH). ON THE OTHER HAND, PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, 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 MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. REVIEW OF MEDICAL RECORD, PATIENT HAD HISTORY OF STREP BACTEREMIA OF UNKNOWN ETIOLOGY AND PRESENTED WITH VEGETATIONS. IN THIS CASE, ENDOCARDITIS IS CHARACTERIZED BY VEGETATIONS THAT ARE ATTACHED TO THE LEAFLETS AND SURROUNDING TISSUE. THESE VEGETATIONS, OVERTIME CAN LEAD TO DEGRADATION. THEREFORE, ENDOCARDITIS COULD AFFECT THE LEAFLETS FUNCTIONALITY/COAPTATION, RESULTING IN CENTRAL REGURGITATION. ADDITIONALLY, ENDOCARDITIS CAN CAUSE INFLAMMATION OF THE SURROUNDING TISSUE IN RESPONSE TO THE INFECTION, WHICH CAN POTENTIALLY LEAD TO LEAKS AROUND THE FRAME AND NATIVE ANNULUS, RESULTING IN THE REPORTED PARAVALVULAR LEAK. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (ENDOCARDITIS) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. 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. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS NOR PRODUCT RISK ASSESSMENT (PRA) IS REQUIRED.
THE INVESTIGATION IS ONGOING. H3 OTHER TEXT: THE VALVE REMAINS IMPLANTED.
PER MEDICAL RECORD REVIEW, A TTE PERFORMED APPROXIMATELY 5 YEARS AND 3 MONTHS POST TAVR PROCEDURE SHOWED MODERATE TO SEVERE AORTIC REGURGITATION (PARAVALVULAR LEAK) WAS PRESENT. THERE WERE 2 PARAVALVULAR JETS PRESENT, AT THE 2-3 O'CLOCK POSITION AND AT THE 9-10 O'CLOCK POSITION ON SAX VIEWS. ADDITIONALLY, THERE IS MILD INTERVALVULAR REGURGITATION.
THE PATIENT UNDERWENT A VALVE EXPLANT APPROXIMATELY 5 YEARS AND 7 MONTHS POST TAVR PROCEDURE. AN EDWARDS SURGICAL VALVE WAS IMPLANTED.
AS REPORTED FROM A CLINICAL STUDY, APPROXIMATELY 5 YEARS AND 3 MONTHS POST TAVR PROCEDURE WITH A 26MM SAPIEN 3 VALVE. AN ECHO SHOWED MODERATE-SEVERE AORTIC INSUFFICIENCY. THE PATIENT HAS BEEN EXPERIENCING INCREASED FATIGUE, AND WOULD LIKE TO PURSUE EXPLANT AND SAVR IN THE NEXT FEW MONTHS. THE DATE FOR INTERVENTION IS CURRENTLY UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1975525 | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LFESCIENCES | 9600TFX26A | 00690103194357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |