BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE

    MDR report key: 22169903 · Received June 9, 2025

    Report

    Report Number
    2015691-2025-04690
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 9, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS WHICH MAY OR MAY NOT REQUIRE A PERMANENT PACEMAKER IMPLANTATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. SICK SINUS SYNDROME (SSS), ALSO CALLED SINUS NODE DYSFUNCTION (SND), IS AN UMBRELLA TERM FOR A GROUP OF ABNORMAL HEART RHYTHMS (ARRHYTHMIAS) PRESUMABLY CAUSED BY A MALFUNCTION OF THE SINUS NODE, THE HEART'S PRIMARY PACEMAKER. BRADYCARDIA-TACHYCARDIA SYNDROME IS A VARIANT OF SICK SINUS SYNDROME IN WHICH SLOW ARRHYTHMIAS AND FAST ARRHYTHMIAS ALTERNATE. IT IS OFTEN ASSOCIATED WITH ISCHEMIC HEART DISEASE AND VALVULAR LESIONS. SICK SINUS SYNDROME IS MORE COMMON IN ELDERLY ADULTS, WHERE THE CAUSE IS OFTEN A NON-SPECIFIC, SCAR-LIKE DEGENERATION OF THE CARDIAC CONDUCTION SYSTEM. CORONARY ARTERY DISEASE, HIGH BLOOD PRESSURE, AND AORTIC AND MITRAL VALVE DISEASES MAY BE ASSOCIATED WITH SICK SINUS SYNDROME, ALTHOUGH THIS ASSOCIATION MAY ONLY BE INCIDENTAL. ACQUIRED SND MAY OCCUR AFTER DAMAGE TO THE SN ARTERY DURING CARDIAC SURGERY OR MAY BE DUE TO OCCLUSION, SUCH AS AFTER MYOCARDIAL INFARCTION. ANOTHER SURGICAL CAUSE OF SND INCLUDES SN TISSUE DAMAGE DURING CANNULATION OF THE SUPERIOR VENA CAVA FOR CARDIOPULMONARY BYPASS OR EXTRACORPOREAL MEMBRANE OXYGENATION. ISCHEMIC CARDIAC ARREST MAY ALSO CAUSE SND. THE NATURAL HISTORY OF SND MAY BE HIGHLY VARIABLE, ALTHOUGH IT TENDS TO BE PROGRESSIVE. THE ONLY EFFECTIVE TREATMENT FOR PATIENTS WITH CHRONIC SYMPTOMATIC SND IS PACEMAKER THERAPY. SLOW HEART RATES OR BRADYCARDIA HAVE MANY POTENTIAL CAUSES INCLUDING DISTURBANCES IN AUTOMATICITY AND CONDUCTION, MEDICATIONS INCLUDING GENERAL ANESTHESIA, ELECTROLYTE IMBALANCES, ADVANCED AGE, AND CARDIAC DISEASES. IF THIS CANNOT BE MANAGED WITH MEDICATION, PERMANENT PACEMAKER IMPLANTATION MAY BE NECESSARY. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE BRADYCARDIA WAS ATTRIBUTED TO PRE-EXISTING PAF 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 THE EDWARDS JAPANESE CLINICAL SPECIALIST, THE PATIENT EXPERIENCED BRADYCARDIA ASSOCIATED WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) ON POSTOPERATIVE DAY 1 POST TAVR WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE, NECESSITATING A PERMANENT PACEMAKER ON DAY 2. APPROXIMATELY 8 MONTHS PRIOR TO THE TAVR, THE PATIENT HAD A CEREBRAL INFARCTION AND WAS ADMITTED TO A NEUROSURGICAL HOSPITAL, WHERE PAF WAS DETECTED, AND LIXIANA (EDOXABAN) WAS INITIATED. LIXIANA WAS STOPPED FOR A TRANSCAROTID (TC) TAVR WITH A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. THE NEXT DAY, BRADYCARDIA AND SYNCOPE DURING PAF LED TO THE PLACEMENT OF A TEMPORARY PACEMAKER, FOLLOWED BY A PERMANENT PACEMAKER ON THE SAME DAY. THE BRADYCARDIA WAS ATTRIBUTED TO PRE-EXISTING PAF, AND NO CAUSAL LINK TO THE VALVE OR TAVR PROCEDURE WAS ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633244 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9755RSL23J

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention