EDWARDS SAPIEN VALVE UNKNOWN
Report
- Report Number
- 2015691-2022-06322
- Event Type
- Death
- Date Received
- June 22, 2022
- Date of Event
- January 1, 2014
- Report Date
- August 9, 2022
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CITATION: GIUDICATTI, LAUREN, ET AL. ''LONG-TERM ECHOCARDIOGRAPHIC FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION TO ASSESS STRUCTURAL VALVE DETERIORATION AND BIOPROSTHETIC VALVE FAILURE.'' HEART, LUNG AND CIRCULATION 31.4 (2022): 559-565. IT IS UNKNOWN WHETHER THE VALVE MODEL IS A SAPIEN OR SAPIEN XT VALVE. THE POSSIBLE VALE USED: SAPIEN TRANSCATHETER HEART VALVE - PMA P110021 OR SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009. INVESTIGATION IS ONGOING.
CORRECTION TO A2, B2, B.5, H1 UPDATE TO B4, G3, G6, H2, AND H10 TO REFLECT ADDITIONAL INFORMATION RECEIVED. AS PER INFORMATION RECEIVED, DETAILED INFORMATION HAS BEEN OBTAINED FOR EACH PATIENT. CASE OF AN IMPLANT OF A 23-MM SAPIEN VALVE BY TRANSAPICAL OR TRANSAORTIC APPROACH. APPROXIMATELY 7 YEARS AND 26 DAYS AFTER THE PROCEDURE ECHO REVEALED SEVERE SVD AND BVF DUE TO WORSENING OF VALVULAR AORTIC REGURGITATION AND OVER 20 MMHG INCREASE IN MEAN AV GRADIENT. PATIENT DIED 7 YEARS AND 4 MONTHS AFTER THE PROCEDURE. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. THERE IS NO INDICATION THAT THE DEATH WAS RELATED TO THE VALVE. BASELINE POST TAVI ECHO SHOWED LVEF WAS 71.8%, LVEDD WAS 4.3, LVESD WAS2.6, MEAN GRADIENT WAS 17 MMHG, PEAK GRADIENT WAS 27 MMHG, PEAK VELOCITY WAS 2.6 M/S, INDETERMINATE DIASTOLIC DYSFUNCTION. FOLLOW-UP ECHO SHOWED LVEF WAS 67.9%, LVEDD WAS 4.5, LVESD WAS 2.8, PSEUDONORMAL DYASTOLIC DYSFUNCTION, MEAN GRADIENT WAS 32 MMHG, PEAK GRADIENT WAS 55 MMHG AND PEAK VELOCITY WAS 3.7 M/S. NO ADDITIONAL INVESTIGATION IS REQUIRED.
ADDED H.6 TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. CORRECTED H.6 INVESTIGATION CONCLUSIONS. THE VALVE WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY. DURING MANUFACTURING OF THE SAPIEN AND SAPIEN XT TRANSCATHETER HEART VALVES, THE VALVE AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. ALL REVIEWED IFU DOCUMENTS PROVIDE SIMILAR WARNINGS, PRECAUTIONS, AND POTENTIAL ADVERSE EVENTS IRRESPECTIVE OF SPECIFIC DELIVERY SYSTEM OR APPROACH USED. ACCELERATED DETERIORATION OF THE THV MAY OCCUR IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. LONG-TERM DURABILITY HAS NOT BEEN ESTABLISHED FOR THE THV. REGULAR MEDICAL FOLLOW-UP IS ADVISED TO EVALUATE VALVE PERFORMANCE. THV RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT THERAPY, AS DETERMINED BY THEIR PHYSICIAN. DEVICE DEGENERATION, STRUCTURAL VALVE DETERIORATION, AND VALVE REGURGITATION ARE ALL LISTED AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. 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. SINCE NO PRODUCT NON-CONFORMANCES WERE IDENTIFIED, A PRODUCT RISK ASSESSMENT (PRA) ESCALATION IS NOT REQUIRED. SINCE NO EDWARDS DEFECTS WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. THE VALVE DEGENERATION WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF MEDICAL RECORDS/APPLICABLE IMAGERY. 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. DURING THE MANUFACTURING PROCESS, ALL SAPIEN / SAPIEN XT VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% 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. REVIEW OF THE MEDICAL PUBLICATION REVEALED THAT 5 PATIENTS WHO UNDERWENT TAVI FROM 01-JAN-2009 TO 29-JAN-2015, WHEREIN EITHER THE SAPIEN OR SAPIEN XT THV WAS POTENTIALLY IMPLANTED, HAD DEVELOPED SVD, AS OBSERVED BY ECHO DURING THE 5-YEAR FOLLOW-UP. PER THE INSTRUCTIONS FOR USE (IFU), STRUCTURAL VALVE DETERIORATION (SVD) AND DEVICE DEGENERATION ARE LISTED AS KNOWN POTENTIAL RISK ASSOCIATED WITH THE DEVICE. 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. AS DISCLOSED IN THE ARTICLE, SVD WAS MORE COMMON IN PATIENTS WITH PRE-EXISTING PERIPHERAL VASCULAR DISEASE, WHICH SUGGESTS THAT PATIENT FACTORS COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, DUE TO INSUFFICIENT INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME.
AS REPORTED THROUGH THE REVIEW OF THE AUSTRALIAN MEDICAL ARTICLE: ''LONG-TERM ECHOCARDIOGRAPHIC FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION TO ASSESS STRUCTURAL VALVE DETERIORATION AND BIOPROSTHETIC VALVE FAILURE'', FROM 1 JANUARY 2009 TO 29 JANUARY 2015, 211 PATIENTS UNDERWENT TAVI PROCEDURE. FORTY-FOUR (44) PATIENTS RECEIVED BALLOON EXPANDABLE SAPIEN OR SAPIEN XT VALVES BY TRANSFEMORAL, TRANSAPICAL OR TRANSAORTIC APPROACH. ALL CASES OF STRUCTURAL VALVE DETERIORATION OCCURRED IN PATIENTS WITH BALLOON EXPANDABLE VALVES. THESE CASES WERE DETECTED WITH FOLLOW-UP ECHOCARDIOGRAM PERFORMED AT A MINIMUM OF 5 YEARS POST TAVI. ONE PATIENT HAD SEVERE STRUCTURAL VALVE DETERIORATION AND BIOPROSTHETIC VALVE FAILURE DUE TO WORSENING OF VALVULAR AORTIC REGURGITATION AND OVER 20 MMHG INCREASE IN MEAN AV GRADIENT.
THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "LONG-TERM ECHOCARDIOGRAPHIC FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION TO ASSESS STRUCTURAL VALVE DETERIORATION AND BIOPROSTHETIC VALVE FAILURE", CORRESPONDING AUTHOR (B)(6), (B)(6)HOSPITAL. FROM 1 JANUARY 2009 TO 29 JANUARY 2015, 211 PATIENTS UNDERWENT TAVI PROCEDURE. 44 PATIENTS HAD BALLOON- EXPANDABLE SAPIEN OR SAPIEN XT BY TRANSFEMORAL, TRANSAPICAL OR TRANSAORTIC APPROACH. ALL CASES OF SVD OCCURRED IN PATIENTS WITH BALLOON-EXPANDABLE VALVES. THESE CASES WERE DETECTED WITH FOLLOW-UP ECHOCHARDIOGRAM PERFORMED AT A MINIMUM OF 5 YEARS POST TAVI. OF THE FIVE PATIENTS WITH SVD, FOUR (4) MET THE CRITERIA FOR MODERATE HAEMODYNAMIC SVD DUE TO PROSTHETIC STENOSIS AND ONE (1) PATIENT HAD SEVERE SVD AND BVF DUE TO WORSENING OF VALVULAR AORTIC REGURGITATION AND OVER 20 MMHG INCREASE IN MEAN AV GRADIENT. AS PER INFORMATION RECEIVED, DETAILED INFORMATION HAS BEEN OBTAINED FOR EACH PATIENT. CASE OF AN IMPLANT OF A 23-MM SAPIEN VALVE BY TRANSAPICAL OR TRANSAORTIC APPROACH. APPROXIMATELY 7 YEARS AND 26 DAYS AFTER THE PROCEDURE ECHO REVEALED SEVERE SVD AND BVF DUE TO WORSENING OF VALVULAR AORTIC REGURGITATION AND OVER 20 MMHG INCREASE IN MEAN AV GRADIENT. PATIENT DIED 7 YEARS AND 4 MONTHS AFTER THE PROCEDURE. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. BASELINE POST TAVI ECHO SHOWED LVEF WAS 71.8%, LVEDD WAS 4.3, LVESD WAS 2.6, MEAN GRADIENT WAS 17 MMHG, PEAK GRADIENT WAS 27 MMHG, PEAK VELOCITY WAS 2.6 M/S, INDETERMINATE DIASTOLIC DYSFUNCTION. FOLLOW-UP ECHO SHOWED LVEF WAS 67.9%, LVEDD WAS 4.5, LVESD WAS 2.8, PSEUDONORMAL DYASTOLIC DYSFUNCTION, MEAN GRADIENT WAS 32 MMHG, PEAK GRADIENT WAS 55 MMHG AND PEAK VELOCITY WAS 3.7 M/S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612231 | EDWARDS SAPIEN VALVE UNKNOWN | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | SAPIEN VALVE UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| D |