BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE / P140031

    MDR report key: 19916768 · Received August 6, 2024

    Report

    Report Number
    2015691-2024-05904
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    February 29, 2024
    Report Date
    August 6, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103217322
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT REPORTED IS AN ANTICIPATED IN THE RISK MANAGEMENT DOCUMENTATION FOR TRANSCATHETER HEART VALVE PROCEDURES. A PREVIOUS INVESTIGATION INTO THIS TYPE OF EVENT IS CAPTURED IN AN EDWARDS LIFESCIENCES TECHNICAL SUMMARY AND APPLIES TO THIS COMPLAINT. ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. PER THE TECHNICAL SUMMARY: THE IFU, CURRENT RISK MITIGATIONS INCLUDING DESIGN AND MANUFACTURING CONTROLS, 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. PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THE IFU CAUTIONS THAT SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS NEAR CORONARY OSTIA. IN ADDITION, IT WARNS THAT CAUTION SHOULD BE EXERCISED IN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE. CORONARY OBSTRUCTION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G., PERCUTANEOUS CORONARY INTERVENTION (PCI). MULTIPLE PATIENT FACTORS COULD PUT THE PATIENT AT RISK FOR CORONARY FLOW OBSTRUCTION DURING THE THV PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. ADDITIONALLY, 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 BALLOON VALVULOPLASTY, 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 BEFORE 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. THE EDWARDS THV MANUALS ALSO 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. DUE TO A LIMITED AMOUNT OF INFORMATION RECEIVED, IT IS UNKNOWN WHAT COULD HAVE 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 BY OUR JAPANESE AFFILIATES, THROUGH THE TAVI REGISTRY, ON THE SAME DAY OF A 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS TRANSFEMORALLY DEPLOYED IN THE AORTIC ANNULUS, AFTER DEPLOYMENT OF THE VALVE, THE PATIENT'S BLOOD PRESSURE DID NOT RISE. ECHOGRAPHY REVEALED CIRCUMFERENTIALLY DECREASED SEPTAL TO LATERAL WALL MOTION. AORTOGRAPHY SHOWED POOR LEFT MAIN TRUNK (LMT) FLOW, SO PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO THE LMT AND MIDDLE LEFT ANTERIOR DESCENDING ARTERY (LAD) UNDER PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). CARDIAC FUNCTION IMPROVED, SO THE PATIENT WAS WEANED FROM THE PCPS AFTER PCI. THE CAUSE OF THE OBSTRUCTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703281 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE / P140031 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9755RSL23J 00690103217322

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention