BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE

    MDR report key: 17863479 · Received October 3, 2023

    Report

    Report Number
    2015691-2023-16295
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    July 1, 2023
    Report Date
    April 10, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 2 CORONARY ARTERY COMPRESSION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE IN THE AORTIC POSITION. THE ''TIME TO EVENT'' (TTE, IN DAYS) FOR THIS EVENT WAS 0.0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO CORONARY OSTIA. CORONARY OCCLUSION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G., PCI). THERE ARE MULTIPLE PATIENT FACTORS THAT COULD CONTRIBUTE TO CORONARY OCCLUSION BY THE PROSTHETIC VALVE OR NATIVE VALVE LEAFLETS, INCLUDING A MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, AND OBLITERATED CORONARY SINUSES. PROCEDURAL FACTORS SUCH AS TORN NATIVE LEAFLET DURING BAV, PLAQUE SHIFT, DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE TO THIS COMPLICATION. THE EDWARDS THV TRAINING MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE PHYSICIAN IS INSTRUCTED TO EVALUATE THIS RISK EARLY IN THE PATIENT SCREENING PROCESS IN ALL PATIENTS THE FOLLOWING FACTORS SHOULD BE CONSIDERED: DEGREE OF CALCIFICATION ON LEAFLETS, ANNULUS TO CORONARY OSTIA DISTANCE, LENGTH OF THE VALVE LEAFLET, WIDTH OF THE VALSALVA SINUSES, MOVEMENT OF THE LEAFLETS DURING BAV, PATENCY OF CORONARIES DURING BAV, AND EXPANDED HEIGHT OF THE INTENDED THV. THE TRAINING MANUALS ALSO PROVIDE THE FOLLOWING TIPS FOR DETECTING RISK FOR LEFT MAIN OCCLUSION: (1) AORTOGRAM OR TEE PRIOR TO THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; (2) DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND (3) CONSIDER AORTOGRAM DURING VALVULOPLASTY TO ASSESS CORONARY FLOW. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. SPECIFIC CLINICAL AND PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. 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 ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MDR CORRECTS SECTION C - COMBINATION DEVICE AND SECTION G4 CHECK BOX FOR COMBINATION PRODUCT. DURING REVIEW OF PREVIOUS SUBMISSIONS, IT WAS OBSERVED THAT THE COMBINATION DEVICE FIELD SECTION G4 WAS MARKED AS TRUE BY THE SYSTEM BECAUSE THE FIELD IN SECTION C WAS LEFT BLANK WHEN THE SUBMISSION WAS INITIALLY POPULATED. THE EW DEVICES SUBMITTED UNDER THIS MANUFACTURING REPORT ARE NOT CONSIDERED COMBINATION DEVICES.

    Description of Event or Problem · 0

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 3 2023 DATA EXTRACT FOR AORTIC SERIOUS INJURY EVENTS FOR THE SAPIEN 3 ULTRA RESILIA VALVE. THIS REPORT SUMMARIZES 2 CORONARY ARTERY COMPRESSION SERIOUS INJURY EVENTS FOR THE SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 77-86 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760930 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9755RSL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Other