BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AS REPORTED BY OUR AFFILIATE IN JAPAN, ACUTE AORTIC REGURGITATION AND HEMODYNA

    MDR report key: 8325948 · Received February 11, 2019

    Report

    Report Number
    2015691-2019-00452
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 24, 2019
    Report Date
    January 24, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE OVERALL TAVR PROCEDURE. PERI-PROCEDURAL VENTRICULAR ARRHYTHMIAS CAN BE ASSOCIATED WITH PATIENT AND PROCEDURAL FACTORS SUCH AS POOR VENTRICULAR FUNCTION, INADEQUATE CORONARY PERFUSION, HYPOVOLEMIA, ANNULAR RUPTURE/ AORTIC DISSECTION, CARDIAC TAMPONADE, WIRE AND CATHETER MANIPULATION AND PROLONGED OR REPETITIVE RUNS OF RAPID PACING. THESE PATIENTS CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. THEY ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE ARRHYTHMIAS AND HYPOTENSION ARE NOT UNCOMMON AND ARE TREATED WITH STANDARD THERAPIES, INCLUDING ADDITIONAL VASOACTIVE DRUGS OR ELECTRICAL CONVERSION. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IF THESE STANDARD MANEUVERS ARE NOT ADEQUATE, INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY MAY BE REQUIRED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES, COMMUNICATION DURING THE PROCEDURE), IN ADDITION TO PATIENT FACTORS (FEMALE GENDER, ADVANCED AGE ¿ (B)(6)) LIKELY CONTRIBUTED TO THE AR AND HEMODYNAMIC INSTABILITY OBSERVED FOLLOWING CROSSING THE NATIVE ANNULUS WITH THE DELIVERY SYSTEM AND VALVE. 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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2019- 00451.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6), ¿ACUTE¿ AORTIC REGURGITATION AND HEMODYNAMIC INSTABILITY WERE OBSERVED AFTER THE COMMANDER DELIVERY SYSTEM AND SAPIEN 3 VALVE CROSS THE NATIVE VALVE. AS REPORTED, DURING A TRANSFEMORAL TAVR PROCEDURE, ACCESS TO THE RIGHT GROIN WAS OBTAINED VIA A SURGICAL CUTDOWN. NO BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. A GUIDEWIRE WAS PLACED ACROSS THE AORTIC VALVE WITHOUT ANY INTERFERENCE WITH THE PAPILLARY MUSCLE, AND THE BLOOD PRESSURE (BP) WAS IN THE 100¿S MMHG. AFTER THE COMMANDER DELIVERY SYSTEM AND 23MM SAPIEN 3 VALVE CROSSED THE AORTIC VALVE, THE BP GRADUALLY DROPPED, ¿ACUTE¿ AORTIC REGURGITATION (AR) AND AN INCREASE IN MITRAL REGURGITATION (MR) WERE OBSERVED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND THE BP DECREASED TO THE 50¿S MMHG AND THE PATIENT¿S PULSE WAS 40 MMHG TO 50 MMHG. SINCE THE VASOPRESSOR WAS ADMINISTERED, RAPID PACING WAS STARTED. THE SAPIEN 3 VALVE WAS POSITIONED 50:50 AORTIC/VENTRICULAR (A/V) AND DEPLOYED WITH NOMINAL VOLUME, LANDING IN A FINAL CANTED POSITION OF 60:40 A/V ON THE NON-CORONARY CUSP (NCC) SIDE AND 70:30 A/V TO 80:20 A/V ON THE LEFT CORONARY CUSP (LCC) SIDE. POST VALVE DEPLOYMENT, THE BP DID NOT RECOVER. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND CARDIAC MASSAGE WERE INITIATED. FOLLOWING THE INSERTION OF THE PCPS, VENTRICULAR FIBRILLATION (VFIB) DEVELOPED. DEFIBRILLATION (DC) WAS EXECUTED AT 150J. AFTER STARTING PCPS, THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP), INITIATED FROM THE RIGHT FEMORAL ARTERY. FOLLOWING FLOW AND VOLUME LOAD ADJUSTMENT, THE HEMODYNAMICS GRADUALLY BECAME STABLE. POST SAPIEN 3 VALVE DEPLOYMENT, MILD PARAVALVULAR LEAK (PVL) WAS OBSERVED AND THE PATIENT¿S OWN PULSE WAS CONFIRMED. THE PCPS AND IABP WERE REMOVED AND THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM IN STABLE CONDITION. THE NATIVE ANNULUS MEASURED 19.4MM BY TTE. MILD VALVULAR CALCIFICATION AND NO AORTIC ROOT CALCIFICATION WAS REPORTED. PER MEDICAL OPINION, VARIOUS FACTORS ¿OVERLAPPED¿ DURING THE PROCEDURE AND MAY HAVE CONTRIBUTED TO THE PRE-VALVE DEPLOYMENT AR AND HEMODYNAMIC INSTABILITY. IT WAS NOTED THAT THE TAVI TEAM MEMBERS HAD CHANGED, RESULTING IN COMMUNICATION ISSUES DURING THE PROCEDURE. THE DELIVERY SYSTEM AND ESHEATH WERE DISCARDED FOLLOWING THE PROCEDURE. THE VALVE REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118083 AS REPORTED BY OUR AFFILIATE IN JAPAN, ACUTE AORTIC REGURGITATION AND HEMODYNA AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS23J 61543972

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention