BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 18717787 · Received February 15, 2024

    Report

    Report Number
    2015691-2024-01077
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    November 27, 2022
    Report Date
    March 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YOON, JOSHUA, ET AL. ''NEOVASCULARIZATION IN STRUCTURAL BIOPROSTHETIC VALVE DYSFUNCTION.'' CARDIOVASCULAR INTERVENTIONS 16.5 (2023): 606-608. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    UPDATED B.4, G.3, G.6, AND H.2. THE VALVE WAS NOT RETURNED FOR EVALUATION. AS NO SERIAL NUMBER WAS PROVIDED, NEITHER A DEVICE HISTORY REVIEW OR LOT HISTORY REVIEW WERE ABLE TO BE PERFORMED. IMAGERY FROM THE ARTICLE WAS REVIEWED. THE VALVE APPEARED TO BE UNDER-EXPANDED WITH AN ELLIPTICAL SHAPE. MICROVESSELS WERE OBSERVED ON THE BIOPROSTHETIC LEAFLETS. THE IFU WAS REVIEWED. PHYSICIANS ARE WARNED THAT ACCELERATED DETERIORATION OF THE VALVE MAY OCCUR IN PATIENTS WITH AN ALTERED CALCIUM METABOLISM. VALVE RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT/ANTIPLATELET THERAPY, EXCEPT WHEN CONTRAINDICATED, AS DETERMINED BY THEIR PHYSICIAN. THIS DEVICE HAS NOT BEEN TESTED FOR USE WITHOUT ANTICOAGULATION. POTENTIAL RISKS ASSOCIATED WITH THE USE OF THE VALVE, DELIVERY SYSTEM, AND/OR ACCESSORIES INCLUDE 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. 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 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. THE VALVE DEGENERATION/DETERIORATION WAS CONFIRMED BASED ON THE PROVIDED MEDICAL ARTICLE. AS NO SERIAL NUMBER WAS PROVIDED, A DHR AND LOT HISTORY REVIEWS WERE UNABLE TO BE PERFORMED. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 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, ''TWO MONTHS AFTER WARFARIN INITIATION (FOUR MONTHS AFTER THE PROCEDURE), A FOLLOW-UP TTE SHOWED FURTHER THV DYSFUNCTION WITH A MEAN GRADIENT OF 39 MM HG. THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL REPLACEMENT WITH A MECHANICAL VALVE. HISTOLOGIC ANALYSIS OF THE EXPLANTED THV SHOWED SEVERE DEGENERATION OF THE LEAFLETS WITH THE DIFFUSE PRESENCE OF MICROVESSELS''. PER THE INSTRUCTIONS FOR USE (IFU), VALVE DEGENERATION OR 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 MANIFEST AS STENOSIS WITH THICKENED LEAFLETS, DUE TO BIOPROSTHETIC TISSUE CALCIFICATION AS THE UNDERLYING FAILURE MODE. TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT 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. IN THIS CASE, THE PATIENT HAD A MEDICAL HISTORY OF DIABETES (DM) AND CHRONIC KIDNEY DISEASE (CKD), WHICH ARE KNOWN TO INCREASE THE RISK FOR DEVELOPING BIOPROSTHETIC VALVE CALCIFICATION. THE RESULTING CO-MORBIDITIES COULD HAVE CAUSED THE VALVE LEAFLETS TO BECOME THICKENED, RESULTING IN THE NARROWING OF EFFECTIVE VALVE AREA (STENOSIS) AND DEGENERATION, AS REPORTED. PER IMAGERY REVIEW, DEPLOYED VALVE WAS UNDER EXAPANDED, WHICH COULD INCREASE THE STRESS ON THE VALVE AND INCREASE GRADIENTS ACROSS THE VALVE. ADDITIONALLY, THEY REPORTED ''LEAFLETS WITH THE DIFFUSE PRESENCE OF MICROVESSELS''. PER ARTICLE ''DEGENERATION OF BIOPROSTHETIC HEART VALVES: UPDATE 2020'', THE HYPOTHESIS SUGGESTS THAT DYSTROPHIC CALCIFICATION CAN BE CAUSED BY THE DEMISE OF RED BLOOD CELLS (RBCS) DIFFUSING INTO BIOPROSTHETIC HEART VALVE (BHV) LEAFLETS UNDER THE INFLUENCE OF BLOOD PRESSURE. IN PARTICULAR, THEIR GROUP REPEATEDLY OBSERVED BLOOD-FILLED CAPILLARY-LIKE CAVITIES IN EXPLANTED BHVS, AS WELL AS ACCUMULATIONS OF RBCS IN AREAS OF TISSUE LOOSENING AND DELAMINATION. INTRALEAFLET HEMORRHAGE IS A SIGN OF THE NATIVE VALVE DEGENERATION AND ASSOCIATES WITH A LOSS OF ENDOTHELIAL INTEGRITY AND NEOVASCULARIZATION. IN SUPPORT OF THE MENTIONED HYPOTHESIS, HEMORRHAGE AREAS IN NATIVE AORTIC VALVES ARE COLOCALIZED WITH THE SITES OF ECTOPIC CALCIFICATION, AND INTRALEAFLET HEMORRHAGE CORRELATES WITH THE PROGRESSION OF CALCIFICATION. POSSIBLY, ACCUMULATION OF IRON FROM DYING RBCS PROVOKES OXIDATIVE STRESS IN THE AFFECTED VALVES AND THUS PROMOTES TRANSITION OF VALVE INTERSTITIAL CELLS (VICS) TO THE OSTEOBLAST PHENOTYPE. SUCH PUTATIVE MECHANISM WOULD NOT WORK FOR BHVS, WHICH ARE DEVOID OF VICS. NEVERTHELESS, DESTRUCTION OF RBCS TRAPPED IN THE BHV CAN LEAD TO OXIDATION-DRIVEN SVD. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (DIABETES, CHRONIC KIDNEY DISEASE) AND/OR PROCEDURAL FACTORS (UNDER EXPANDED VALVE) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    A REVIEW OF MEDICAL ARTICLE ''NEOVASCULARIZATION IN STRUCTURAL BIOPROSTHETIC VALVE DYSFUNCTION'' WAS PERFORMED. A 23MM SAPIEN 3 VALVE WAS IMPLANTED IN THE AORTIC POSITION WITH A MEAN GRADIENT OF 15MMHG AT DISCHARGE ON TRANSTHORACIC ECHOCARDIOGRAPHY. THEY PRESENTED WITH EARLY BIOPROSTHETIC VALVE FAILURE JUST 2 MONTHS AFTER THE UNEVENTFUL PROCEDURE, INCLUDING A RECURRENCE OF NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS III SYMPTOMS AND TTE REVEALED A MEAN GRADIENT OF 30MMHG. ON COMPUTED TOMOGRAPHY THE THV WAS FOUND TO BE UNDER-EXPANDED AND ELLIPTICAL. ALTHOUGH THE CT WAS NONDIAGNOSTIC FOR VALVE THROMBOSIS, THE PATIENT WAS INITIATED ON WARFARIN DUE TO CLINICAL SUSPICION. TWO MONTHS AFTER WARFARIN INITIATION (FOUR MONTHS AFTER THE PROCEDURE), A FOLLOW-UP TTE SHOWED FURTHER THV DYSFUNCTION WITH A MEAN GRADIENT OF 39MMHG. THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL REPLACEMENT WITH A MECHANICAL VALVE. HISTOLOGIC ANALYSIS OF THE EXPLANTED THV SHOWED SEVERE DEGENERATION OF THE LEAFLETS WITH THE DIFFUSE PRESENCE OF MICROVESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908783 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention