BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 8430802 · Received March 18, 2019

    Report

    Report Number
    2015691-2019-00930
    Event Type
    Death
    Date Received
    March 18, 2019
    Date of Event
    January 30, 2019
    Report Date
    February 25, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION INDICATED NO DYSFUNCTION OF THE SAPIEN 3 VALVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH. REVIEW OF THE MEDICAL RECORDS PROVIDED BY THE FACILITY REVEALED THAT THE PATIENT WAS VERY ILL PRIOR TO THE TAVR PROCEDURE. PRE-TAVR, THE PATIENT¿S EF WAS 21%, POST TAVR THE EF WAS 25%. DURING THE TAVR PROCEDURE, THE VALVE WAS SUCCESSFULLY DEPLOYED WITH MILD AORTIC INSUFFICIENCY. IMMEDIATELY POST DEPLOYMENT THE PATIENT WAS ASYSTOLIC RESULTING IN INTUBATION FOR RESPIRATORY FAILURE, CPR AND AN IMPELLA DEVICE PLACED (REMOVED ON THE NEXT DAY). THE PATIENT WAS TRANSFERRED IN CRITICAL CONDITION. THERE WAS NO INDICATION OF A VALVE DYSFUNCTION OR ANY PATIENT INJURY DUE TO AN EDWARDS DEVICE. ECHO, PERFORMED ON POSTOPERATIVE DAY (POD) 3, INDICATED A WELL SEATED VALVE, LOW GRADIENTS AND MILD PARAVALVULAR LEAK (PVL). THE PATIENT DEVELOPED ACUTE OR CHRONIC HYPERCAPNIC RESPIRATORY FAILURE REQUIRING AGGRESSIVE DIURESIS. ON POD3, THE PATIENT WAS EXTUBATED. ON POST-OPERATIVE (POD) 5, THE CARDIOLOGIST NOTED THE PATIENT SHOWED ¿GOOD CLINICAL IMPROVEMENT¿. ON POD6, THE PATIENT DEVELOPED A UTI INFECTION AND WAS TREATED WITH ANTIBIOTICS. ON POD9, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY IN STABLE CONDITION. THE 30 DAY FOLLOW-UP ECHO INDICATED NORMAL VALVE FUNCTION AND MILD PVL, ELEVATED PULMONARY ARTERY SYSTOLIC PRESSURE, ESTIMATED AT 47 MMHG. IN A SIDE BY SIDE COMPARISON WITH THE POD3 ECHO, THE 30-DAY ECHO INDICATED THE PVL WAS ¿VISUALLY REDUCED¿ AND EF WAS UNCHANGED, VISUALIZED IN THE 25-30%. ON POD34 THE PATIENT WAS ADMITTED WITH ACUTE ON CHRONIC CHF. DURING ADMISSION THE PATIENT WAS ON ACUTE KIDNEY INSUFFICIENCY (AKI) ON CHRONIC KIDNEY DISEASE STAGE 4, EXPERIENCED VENTRICULAR TACHYCARDIA WITH DEACTIVATION OF DEFIBRILLATOR, HAD A GI BLEEDING, AND WORK-UP WAS PERFORMED FOR CONGESTIVE HEPATOPATHY. THE PATIENT LATER BECAME SEPTIC WITH RESPIRATORY DISTRESS. THE SOURCE OF THE SEPSIS WAS NOT PROVIDED. THE PATIENT WAS PLACED ON PALLIATIVE CARE. FOLLOWING DISCUSSION WITH THE FAMILY, THE PATIENT WAS MADE DNR AND PLACED ON COMFORT CARE. THE FAMILY HAD A HARD TIME UNDERSTANDING AND ACCEPTING THE SEPTIC CONDITION OF THE PATIENT. THE PATIENT EXPIRED ON POD50. THE REPORTED CAUSE OF DEATH WAS ACUTE ON CHRONIC SYSTOLIC CHF, VENTRICULAR TACHYCARDIA AND ACUTE RENAL FAILURE. THERE WAS NO INDICATION THAT A VALVE DYSFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. PER THE INSTRUCTION FOR USE (IFU), HEART FAILURE IS A POTENTIAL RISK ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. CONGESTIVE HEART FAILURE CAN HAVE MULTIPLE ETIOLOGIES AND IS OFTEN DUE TO THE PROGRESSION OF UNDERLYING DISEASE PROCESSES, INCLUDING CORONARY ARTERY DISEASE, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, FLUID OVERLOAD, OR VALVULAR DYSFUNCTION. RISK FACTORS THAT INCREASE A PATIENT¿S RISK OF SUFFERING FROM CHF INCLUDE OBESITY, ADVANCED AGE, AND A HISTORY OF SMOKING. 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. ALTHOUGH IN THIS CASE, THE CAUSE OF THE CHF AND VENTRICULAR TACHYCARDIA CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE PATIENT¿S HISTORY OF HEART DISEASE, ADVANCED AGE, AND UNDERLYING COMORBIDITIES (AS, CAD S/P CABG, PERSISTENT ATRIAL FIBRILLATION, AND ISCHEMIC CARDIOMYOPATHY WITH DUAL IDC IN PLACE) CAUSED OR CONTRIBUTED TO THE EVENTS. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THV/TVT REGISTRY. (B)(4). EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY, A TELEPHONE CALL WAS RECEIVED FROM A TAVR PATIENT¿S FAMILY MEMBER REPORTING THAT THE PATIENT EXPIRED. THE FAMILY MEMBER STATED ¿THE VALVE FAILED. MY FATHER NEVER RECOVERED.¿ THE PATIENT EXPIRED 50 DAYS POST DEPLOYMENT OF A 26MM SAPIEN 3 VALVE. DURING THE TRANSFEMORAL TAVR PROCEDURE, THE SAPIEN 3 VALVE WAS SUCCESSFULLY DEPLOYED IN A FINAL 70:30 AORTIC/VENTRICULAR (A/V) POSITION. AN IMPELLA DEVICE WAS UTILIZED DURING THE PROCEDURE TO AID HEART RECOVERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223953 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death