EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-00496
- Event Type
- Injury
- Date Received
- January 18, 2024
- Date of Event
- January 4, 2022
- Report Date
- April 9, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P110021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. ERLEBACH, MAGDALENA, ET AL. ''THE 10-YEAR HORIZON: SURVIVAL AND STRUCTURAL VALVE DEGENERATION IN FIRST-GENERATION TRANSCATHETER AORTIC VALVES.'' ARCHIVES OF CARDIOVASCULAR DISEASES 115.6-7 (2022): 369-376. PER THE INSTRUCTIONS FOR USE (IFU), STRUCTURAL VALVE DETERIORATION (WEAR, FRACTURE, CALCIFICATION, LEAFLET TEAR/TEARING FROM THE STENT POSTS, LEAFLET RETRACTION, SUTURE LINE DISRUPTION OF COMPONENTS OF A PROSTHETIC VALVE, THICKENING, STENOSIS), AND DEVICE DEGENERATION ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. THE IFU CAUTIONS THAT ACCELERATED DETERIORATION OF THE VALVE MAY OCCUR IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. LONG-TERM DURABILITY HAS NOT BEEN ESTABLISHED FOR THE VALVE. REGULAR MEDICAL FOLLOW-UP IS ADVISED TO EVALUATE VALVE PERFORMANCE. STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS. 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 YET 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. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. 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. 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.
UPDATED B.4, G.3, G.6, AND H.2. DURING ADMINISTRATIVE REVIEW THE ENGINEERS DETERMINED A MORE APPROPRIATE CODE WAS APPLICABLE. CORRECTED H.6 INVESTIGATION FINDINGS ACCORDINGLY.
CORRECTED H.6 TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. THE VALVE WAS NOT RETURNED FOR EVALUATION. AS NO SERIAL NUMBER FOR THE VALVE WAS PROVIDED, NEITHER A DEVICE HISTORY REVIEW OR LOT HISTORY REVIEW WERE ABLE TO BE PERFORMED. SINCE NO DEVICE PROBLEM WAS IDENTIFIED AFFECTING DISTRIBUTED PRODUCT, NO PRODUCT RISK ASSESSMENT (PRA) IS REQUIRED. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT, WAS CONFIRMED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. 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. 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 THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE VALVE DEGENERATION WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF MEDICAL RECORD/APPLICABLE IMAGERY. DUE TO UNAVAILABILITY OF VALVE SERIAL NUMBER, DHR REVIEW WAS UNABLE TO BE PERFORMED TO DETERMINE IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% FUNCTIONALLY TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. IN ADDITION, DURING VALVE ASSEMBLY, LEAFLET TISSUE IS SUBMITTED TO THICKNESS MEASUREMENTS. PER THE INSTRUCTIONS FOR USE (IFU), STRUCTURAL VALVE DETERIORATION (WEAR, FRACTURE, CALCIFICATION, LEAFLET TEAR/TEARING FROM THE STENT POSTS, LEAFLET RETRACTION, SUTURE LINE DISRUPTION OF COMPONENTS OF A PROSTHETIC VALVE, THICKENING, STENOSIS), AND DEVICE DEGENERATION ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH THE DEVICE. 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 YET 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 INSUFFICIENT INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED.
UPDATED B.4, G.3, AND H.2. PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2023-18408, 2015691-2023-18411, 2015691-2023-00497, 2015691-2023-00498, AND 2015691-2023-00499.
AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, A REVIEW OF MEDICAL ARTICLE ''THE 10-YEAR HORIZON: SURVIVAL AND STRUCTURAL VALVE DEGENERATION IN FIRST-GENERATION TRANSCATHETER AORTIC VALVES'' WAS PERFORMED. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE (1) PATIENT WITH AN UNKNOWN ORIGINAL SAPIEN VALVE PRESENTED WITH STRUCTURAL VALVE DETERIORATION LEADING TO CENTRAL REGURGITATION THAT REQUIRED A REINTERVENTION WITH A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 3.4 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1579448 | EDWARDS SAPIEN TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9000TFX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Unknown | Required Intervention |