BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER, 20MM

    MDR report key: 18669818 · Received February 8, 2024

    Report

    Report Number
    2015691-2024-00854
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    October 25, 2021
    Report Date
    March 7, 2024
    Manufacturer
    EDWARDS WAY
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. BIBLIOGRAPHY: LEE, SEUNG-AH, ET AL. "IDENTIFICATION OF CT-DERIVED INTERNAL AREA IN FAILED SURGICAL STENTED BIOPROSTHESES FOR VALVE-IN-VALVE IMPLANTATION." RADIOLOGY: CARDIOTHORACIC IMAGING 5.6 (2023): E230103. THIS REPORT IS 6 OF 6 BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NO. 2015691-2024-00841, 2015691-2024-00839, 2015691-2024-00843, 2015691-2024-00844, AND 2015691-2024-00846. H3 OTHER TEXT : PER ARTICLE THE VALVE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED BASED ON THE NO PRODUCT INVESTIGATION. UPDATE TO H6 INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS) AND H10 TO REFLECT DEVICE EVALUATION. PER THE INSTRUCTIONS FOR USE (IFU), NONSTRUCTURAL DYSFUNCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THE IFU CAUTIONS THAT INCORRECT SIZING OF THE VALVE MAY LEAD TO RESIDUAL GRADIENT (PATIENT PROSTHESIS MISMATCH). IN THE AORTIC POSITION, SEVERE PPM IS DEFINED BY AN INDEXED EFFECTIVE ORIFICE AREA OF <0.65 CM2/M2, AND THE INCIDENCE OF SEVERE PPM AFTER SURGICAL AORTIC VALVE REPLACEMENT RANGES BETWEEN 2% AND 20%. PATIENT PROSTHESIS MISMATCH (PPM) HAS TYPICALLY REFERRED TO A SITUATION IN WHICH THE EFFECTIVE VALVE AREA AFTER SURGICAL VALVE REPLACEMENT IS LESS THAN THAT OF A NORMAL HUMAN VALVE. LITERATURE REVIEW SUGGEST THAT PREDICTORS OF PPM AFTER SURGICAL AORTIC VALVE REPLACEMENT INCLUDE OLDER AGE, FEMALE SEX, HYPERTENSION, DIABETES MELLITUS, RENAL FAILURE, LARGER BODY SURFACE AREA, LARGER BODY MASS INDEX, AND THE UTILIZATION OF A BIOPROSTHESIS. FURTHERMORE, THE PRESENCE OF PPM IS PROGNOSTICALLY IMPORTANT BECAUSE PPM RESULTS IN HIGHER VALVE GRADIENTS AND INCREASED PERIOPERATIVE AND OVERALL MORTALITY. THE DEVICE TRAINING MANUALS INSTRUCT THE OPERATOR TO CONSIDER ALL PROCEDURAL AND ANATOMICAL FACTORS. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE DEVICE SYSTEM. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY IN CONJUNCTION WITH ECHOCARDIOGRAPHY FOR OPTIMAL VISUALIZATION DURING POSITIONING AND DEPLOYMENT. THE IFU CAUTIONS THAT RESIDUAL MEAN GRADIENT MAY BE HIGHER IN A 'THV-IN-FAILING PROSTHESIS' CONFIGURATION THAN THAT OBSERVED FOLLOWING IMPLANTATION OF THE VALVE INSIDE A NATIVE AORTIC ANNULUS USING THE SAME SIZE DEVICE. PATIENTS WITH ELEVATED MEAN GRADIENT POST PROCEDURE SHOULD BE CAREFULLY FOLLOWED. 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THAT PATIENT AND/OR PROCEDURAL FACTORS 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. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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.

    Description of Event or Problem · 0

    AS REPORTED THROUGH A PROSPECTIVE SINGLE CENTER STUDY FROM A EUROPEAN JOURNAL ARTICLE, "IDENTIFICATION OF CT-DERIVED INTERNAL AREA IN FAILED SURGICAL STENTED BIOPROSTHESES FOR VALVE-IN-VALVE IMPLANTATION". THE STUDY WAS FROM JUNE 2014 TO DECEMBER 2022 OF 28 CONSECUTIVE PARTICIPANTS WHO UNDERWENT A VALVE-IN-VALVE (VINV) PROCEDURE. THE PARTICIPANTS WHO UNDERWENT VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT, HYPOATTENUATING INTRA-ANNULAR MATERIAL WITHIN THE FAILED SURGICAL BIOPROSTHESIS REDUCED THE CT-DERIVED INTERNAL AREA AND INTERFERED WITH EXPANSION OF INTRA-ANNULAR POSITIONED IMPLANTED VALVES, LEADING TO POSTPROCEDURAL PATIENT-PROSTHESIS MISMATCH. THIS COMPLAINT IS AN 77-YEAR-OLD FEMALE WITH A SAPIEN 3 VALVE WHO DEVELOPED SEVERE PATIENT-PROSTHESIS MISMATCH (PPM) AFTER THE VALVE-IN-VALVE (V-I-V) PROCEDURE. POST PROCEDURAL ECHO REVEALED MEAN PEAK GRADIENT 33 MMHG WITH AORTIC VALVE AREA (AVA) 0.73 CM2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193037 EDWARDS SAPIEN 3 TRANSCATHETER, 20MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS WAY 9600TFX20

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention