BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17374949 · Received July 21, 2023

    Report

    Report Number
    2015691-2023-14762
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    March 2, 2023
    Report Date
    July 21, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ARE INCONCLUSIVE AS EXTENSIVE PATIENT AND PROCEDURAL FACTORS WERE NOT PROVIDED. HOWEVER, IT MAY BE RELATED THE PATIENT'S HISTORY OF HEART VALVE DISEASE . 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. H3 OTHER TEXT: NA.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE P3E CLINICAL STUDY, APPROXIMATELY 5 YEARS AND 10 MONTHS POST TAVR PROCEDURE, THE PATIENT PRESENTED WITH ASSOCIATED CHEST HEAVINESS. TTE REVEALED TRACE AORTIC VALVE INSUFFICIENCY AND ELEVATED PEAK VELOCITY FROM PRIOR STUDY. CTA WAS NEGATIVE FOR PULMONARY EMBOLISM. ON POD 15, TEE REVEALED TRACE-MILD AORTIC VALVE REGURGITATION, WITH CENTRAL JET. PER CLINICAL REVIEW OF MEDICAL RECORDS, TEE PERFORMED 5 YEARS AND 11 MONTHS POST TAVR PROCEDURE REVEALED LV EF 60-65%. BIOPROSTHETIC AORTIC VALVE IS WELL SEATED WITH ROCKING MOTION. LEAFLETS APPEAR THICKENED, BUT MINIMAL RESTRICTED AORTIC VALVE LEAFLET MOTION. TRACE TO MILD AORTIC REGURGITATION, CENTRAL JET. NO THROMBUS OR VEGETATION. ADDITIONAL INFORMATION INDICATES THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS SIX YEARS AND TWO MONTHS POST VALVE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873800 EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29A 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention