SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-04001
- Event Type
- Injury
- Date Received
- May 30, 2024
- Date of Event
- January 17, 2024
- Report Date
- July 15, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO H6; DEVICE CODE, AND INVESTIGATION FINDINGS. UPDATE TO B5. 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. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THAT PATIENT FACTORS (HYPERLIPIDEMIA) AND THE MECHANISMS ABOVE MAY HAVE 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.
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. INVESTIGATION RESULTS SUGGEST/INDICATE THAT PATIENT FACTORS (HALT AND HAM) AND THE MECHANISMS LISTED ABOVE MAY HAVE 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. 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.
THE BELOW VERBIAGE WAS INADVERTENTLY LEFT OUT OF THE PREVIOUS SUBMISSION. 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. SINCE NO EDWARDS PRODUCT DEFECTS OR LABELING DEFICIENCIES WERE IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.
APPROXIMATELY 8 YEARS AND 3 MONTHS POST TAVR PROCEDURE USING 23MM SAPIEN 3 VALVE, THE PATIENT PRESENTED WITH STENOSIS AND PARAVALVULAR LEAK (PVL). THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE (VIV) WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE VIA A CAROTID APPROACH.
APPROXIMATELY 7 YEARS AND 9 MONTHS POST-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23MM SAPIEN 3 VALVE, THE SITE COMMUNICATED THAT HALT WAS SEEN ON CARDIAC COMPUTED TOMOGRAPHY (CT) AND THEY ARE GOING TO ANTICOAGULATE THE PATIENT AND REASSESS IN 3 MONTHS. PER MEDICAL REVIEW, THE 7-YEAR TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED THAT THERE WAS A WELL-SEATED BIOPROSTHETIC VALVE IN THE AORTIC POSITION, WHICH APPEARS TO HAVE RESTRICTED MOTION OF AT LEAST 1 PROSTHETIC LEAFLET; HOWEVER, VISUALIZATION OF THE VALVE LEAFLET IS LIMITED DUE TO SHADOWING. THERE IS MODERATE PARAVALVULAR LEAK (PVL). THE AORTIC VALVE MEAN GRADIENT (AVMG) WAS 18MMHG WITH AN AORTIC VALVE AREA OF 0.95 CM2. FINDINGS CAN BE SEEN IN THE SETTING OF PATIENT PROSTHESIS MISMATCH, MIXED STENOSIS/REGURGITATION WITH INCREASED FLOW STATE, AND INCONSISTENT WITH SEVERE PROSTHETIC STENOSIS AS THE SOLE PATHOLOGY. THE CARDIAC CT SHOWS A WELL-SEATED VALVE WITH REDUCED LEAFLET EXCURSION (HAM) AND HYPOATTENUATED LEAFLET THICKENING (HALT). THE PATIENT WAS EVALUATED FOR A VALVE-IN-VALVE (VIV) TAVR IN DECEMBER AND STARTED ON MEDICATION. THE PATIENT'S CASE IS TO BE DISCUSSED WITH THE CARDIOLOGIST AND HEART VALVE TEAM. THE RECOMMENDATIONS NOTED WERE TO START THE PATIENT ON ORAL ANTICOAGULATION (OAC) ONCE HEMOGLOBIN AND HEMATOCRIT (H/H) ARE STABILIZED AND TO REPEAT IMAGING IN 2-3 MONTHS. TO NOTE, THE PATIENT DOES NOT HAVE ANY FEMORAL ACCESS AND WOULD REQUIRE OPEN AXILLARY ACCESS WITH GENERAL ENDOTRACHEAL ANESTHESIA (GETA), ALSO THE PATIENT'S RIGHT CORONARY ARTERY (RCA) HAS SEVERE STENOSIS THAT WOULD REQUIRE IN-DEPTH REVIEW WITH THE HEART TEAM. IT WAS LATER INDICATED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT THE SITE IS REVISITING A VALVE-IN-VALVE PROCEDURE AS THE PATIENT IS DOING BETTER BUT STILL HIGHLY SYMPTOMATIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1100013 | SAPIEN 3 TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9600TFX23A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Required Intervention |