BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3243927 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20663
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS ARE AVAILABLE FROM THE HOSPITAL; HOWEVER, THEY HAVE NOT BEEN RECEIVED DUE TO THEIR PROCESSING TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN AND IF NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DISCHARGE SUMMARY AND OTHER MEDICAL RECORDS PROVIDED BY THE FACILITY, THE PATIENT WAS ORIGINALLY ADMITTED WITH INCREASING DYSPNEA AND CONGESTIVE HEART FAILURE. HE WAS DISCOVERED TO HAVE CRITICAL AORTIC VALVE STENOSIS AFTER BEING ADMITTED AND WAS HYPOXEMIC. CARDIAC CATHETERIZATION REVEALED NON-CRITICAL CORONARY ARTERY DISEASE. THE PATIENT ALSO HAS A HISTORY OF SEVERE UNDERLYING PULMONARY DISEASE AND, PER PULMONARY CONSULTATION, THE PATIENT WAS FOUND TO HAVE SEVERE RESTRICTION UPON PULMONARY FUNCTION TESTING (PFT). BASED ON THIS, THE PATIENT WAS DEEMED NOT A GOOD SURGICAL CANDIDATE AND WAS SCREENED FOR THE TAVR PROCEDURE. PER THE OPERATIVE REPORT, THE PATIENT UNDERWENT A SUCCESSFUL UNCOMPLICATED TAVR WITH A 26MM SAPIEN VALVE THROUGH A RIGHT FEMORAL APPROACH. POST DEPLOYMENT THERE WAS ONLY MILD PARAVALVULAR LEAK; THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND HAD AN UNREMARKABLE HOSPITALIZATION COURSE. AT THE END OF THE TAVR PROCEDURE, AORTOGRAPHY SHOWED PATENT LEFT AND RIGHT CORONARY ARTERY OSTIA. THE PATIENT WAS TAKEN TO CCU IN STABLE CONDITION. TWO DAYS LATER, HE WAS TRANSFERRED TO THE FLOOR AFTER SUCCESSFUL EXTUBATION. HE HAD INTERMITTENT HYPERTENSIVE EPISODES WHICH WERE CONTROLLED BY HOLDING THE HYDROCHLOROTHIAZIDE. A CARDIAC MRI WITHOUT CONTRAST WAS PERFORMED PRIOR TO DISCHARGE, WHICH SHOWED THAT THE PROSTHETIC VALVE WAS WELL SEATED IN THE AORTIC ROOT WITH NO SUGGESTION OF AORTIC INSUFFICIENCY POST VALVE PLACEMENT. THE PATIENT HAD HYPERDYNAMIC LV SYSTOLIC FUNCTION ¿ LVEF 82% AND NORMAL RIGHT VENTRICULAR SYSTOLIC FUNCTION. FIVE DAYS AFTER TAVR, THE PATIENT CONTINUED TO BE STABLE AND WAS TRANSFERRED TO INPATIENT REHAB. THIS (B)(6) MALE BASELINE MEDICAL HISTORY INCLUDED: SEVERE AORTIC STENOSIS, NEW ONSET ACUTE HEART FAILURE, CAD, SEVERE PULMONARY FUNCTION INSUFFICIENCY DUE TO RESTRICTIVE LUNG DISEASE, HYPERTENSION, HYPERLIPIDEMIA, RIGHT INTERNAL CAROTID STENOSIS, DIABETES MELLITUS TYPE 2, CHRONIC BLE VENOUS STASIS, S/P BILATERAL SAPHENOUS VEINS ABLATIONS, OBESITY HYPERVENTILATION SYNDROME, ACUTE KIDNEY INSUFFICIENCY. THE CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE PATIENT¿S DEMISE 8 DAYS AFTER SUCCESSFUL TAVR PROCEDURE. PER THE INFORMATION RECEIVED, WE CAN SPECULATE ABOUT THE POSSIBILITY THAT THE EVENT WAS ASSOCIATED TO THE PATIENT¿S COMORBIDITIES. UPON ADMISSION, HE WAS REPORTED TO HAVE POOR LUNG FUNCTION, WHICH REMAINED THROUGHOUT THE HOSPITALIZATION. THE PATIENT LEFT THE OR IN STABLE CONDITION AND THE ADMISSION COURSE WAS OTHERWISE UNEVENTFUL. THE CARDIAC MRI PERFORMED ONE WEEK PRIOR TO THE PATIENT¿S DEMISE REPORTED THAT THE SAPIEN VALVE WAS WELL SEATED WITH NO SUGGESTION OF AI. THE DEVICE IS NOT AVAILABLE FOR EVALUATION; THERE IS NO INDICATION THAT AN AUTOPSY WAS PERFORMED. IT APPEARS THAT THE VALVE REMAINS IMPLANTED IN THE PATIENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE INSTRUCTIONS FOR USE (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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES WAS NOTIFIED THROUGH THE THV IMPLANT REGISTRY THAT THE PATIENT PASSED AWAY IN HIS SLEEP 13 DAYS AFTER THE IMPLANTATION OF A SAPIEN VALVE. THE CAUSE OF DEATH IS UNKNOWN. AT THIS TIME THERE IS NO INDICATION THAT AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY TO THE EDWARDS¿S FIELD CLINICAL SPECIALIST: THE PATIENT WAS DOING FINE AFTER THE TAVR PROCEDURE AND WAS DISCHARGED IN STABLE CONDITION. AT THE TIME OF PATIENT¿S DEMISE THE PATIENT WAS NOT HOSPITALIZED AT THE IMPLANTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343068 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death