BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 15584393 · Received October 11, 2022

    Report

    Report Number
    2015691-2022-08502
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    July 5, 2020
    Report Date
    December 13, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    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: SHABADI, RAHUL, ET AL. ''THE ROLE OF ECHOCARDIOGRAPHY IN THE MANAGEMENT OF STRUCTURAL VALVE DEGENERATION OF TRANSCATHETER VALVES.'' ANNALS OF CARDIAC ANAESTHESIA 25.1 (2022): 89. REFERENCE TO PREVIOUSLY REPORTED EVENTS FROM 2015: 2015691-2015-01087 AND 2015691-2015-01086. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. INVESTIGATION IS ONGOING. NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2022-08505. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    UPDATED H.6 CODES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND DID NOT REVEAL COMPLAINTS RELATING TO VALVE DEGENERATION. DURING MANUFACTURING OF THE SAPIEN XT TRANSCATHETER HEART VALVE, 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. IMAGERY WAS PROVIDED AND REVIEWED. THE VALVE'S LEAFLETS WERE OBSERVED TO BE THICKENED WITH RESTRICTED MOTION. AN IMAGE WAS PROVIDED SHOWING THE INCIDENT VALVE EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE IFU WAS REVIEWED. ACCELERATED DETERIORATION DUE TO CALCIFIC DEGENERATION OF THE BIOPROSTHESIS (AS WITH ANY GLUTARALDEHYDE CROSS LINKED BIOPROSTHESIS) MAY OCCUR IN PATIENTS WITH ALTERED CALCIUM METABOLISM. BIOPROSTHETIC VALVE RECIPIENTS SHOULD BE MAINTAINED ON ANTICOAGULANT THERAPY, EXCEPT WHERE CONTRAINDICATED, AS DETERMINED BY THEIR PHYSICIAN. TISSUE DETERIORATION ASSOCIATED WITH BIOPROSTHETIC HEART VALVES CAN BE CAUSED BY CALCIFICATION, THICKENING, AND 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 PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION IS NOT REQUIRED. SINCE NO MANUFACTURING NON-CONFORMANCES OR IFU DEFICIENCIES WERE IDENTIFIED, CORRECTIVE ACTION IS NOT REQUIRED. THE VALVE DEGENERATION/DETERIORATION WAS CONFIRMED FROM PROVIDED IMAGERY. A REVIEW OF THE DHR, LOT HISTORY, AND COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN XT 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. VALVE DEGENERATION IS A KNOWN POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT. 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 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 LIMITED INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    PER THE ARTICLE RECEIVED FROM OMAN, TITLED ''THE ROLE OF ECHOCARDIOGRAPHY IN THE MANAGEMENT OF STRUCTURAL VALVE DEGENERATION OF TRANSCATHETER VALVES'', THE PATIENT UNDERWENT DOUBLE VALVE REPLACEMENT IN 2006, RECEIVING SURGICAL HEART VALVES IN BOTH THE MITRAL AND AORTIC POSITIONS. IN 2015, THE PATIENT DEVELOPED STENOTIC DEGENERATION OF BOTH BIOPROSTHETIC VALVES. DUE TO THE PATIENT'S CLINICAL CONDITION, PATIENT WAS PREGNANT, THE DECISION WAS MADE TO PERFORM TRANSAPICAL TRANSCATHETER VALVE-IN-VALVE IMPLANTATION WITH 23MM AND 29MM SAPIEN XT TRANSCATHETER HEART VALVES IN THE AORTIC AND MITRAL POSITIONS, RESPECTIVELY. FOUR YEARS LATER, APPROXIMATELY IN 2019, THE PATIENT PRESENTED TO THE CARDIOLOGY CLINIC WITH PROGRESSIVE INCREASE IN DYSPNEA AND WAS DIAGNOSED WITH STRUCTURAL VALVE DEGENERATION (SVD) OF THE PROSTHETIC VALVES. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED MODERATE MITRAL STENOSIS WITH A MEAN GRADIENT OF 6 MMHG. IN ADDITION, THE AORTIC VALVE WAS SEVERELY STENOTIC WITH A MEAN GRADIENT OF 70 MMHG WITH MODERATE TRANSVALVULAR REGURGITATION. MITRAL VALVE AREA BY 3D QUANTIFICATION PLANIMETRY WAS 1 CM2 AND AORTIC LEAFLETS WERE THICKENED. A MITRAL VALVE REPLACEMENT WITH MECHANICAL ST. JUDE VALVES WAS SUCCESSFULLY PERFORMED IN BOTH THE MITRAL AND AORTIC POSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2896086 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention