BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29 MM

    MDR report key: 9968059 · Received April 16, 2020

    Report

    Report Number
    2015691-2020-11481
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    December 5, 2019
    Report Date
    March 31, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH AORTIC VALVE REPLACEMENT. POST PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS CAN BE ASSOCIATED WITH PATIENT FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, CARDIAC TAMPONADE, HYPOVOLEMIA OR ELECTROLYTE DEFICIENCIES (E.G. HYPOKALEMIA, HYPOCALCEMIA, HYPOMAGNESEMIA).  THIS PATIENT POPULATION IS TYPICALLY ELDERLY, MAY BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES, MULTIPLE CO-MORBIDITIES, AND LOWER CARDIAC RESERVE THAT CAN LIMIT THEIR ABILITY TO RECOVER FROM THE MEDICAL CONDITIONS ABOVE.  IN THE ABSENCE OF VALVE DYSFUNCTION OR VALVE RELATED ISCHEMIA, POST-PROCEDURE AND LATE VENTRICULAR ARRHYTHMIAS ARE HIGHLY UNLIKELY TO BE RELATED TO THE IMPLANTED VALVE. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED BY EDWARDS LIFESCIENCES IN A ¿CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS-CONDUCTION DISTURBANCES/ HEART BLOCK¿, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED VENTRICULAR FIBRILLATION AND CONDUCTION DISORDER WERE UNABLE TO BE DETERMINED, BUT MAY HAVE BEEN DUE TO PATIENT AND/OR PROCEDURAL FACTORS NOT PROVIDED AND THE MECHANISMS EXPLAINED ABOVE. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), A 29 MM SAPIEN 3 VALVE WAS IMPLANTED IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. ON POST-OPERATIVE DAY (POD) 1 THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION AND CONDUCTION DISORDER. A TEMPORARY PACEMAKER WAS PLACED. POD 6, A PERMANENT PACEMAKER (PPM) WAS IMPLANTED AND THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430129 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29 MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29J

    Patients

    Seq Age Sex Outcome Treatment
    1