BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TRANSCATHETER HEART VALVE

    MDR report key: 10988258 · Received December 10, 2020

    Report

    Report Number
    2015691-2020-14949
    Event Type
    Death
    Date Received
    December 10, 2020
    Date of Event
    October 1, 2009
    Report Date
    November 17, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2020-14942, 2015691-2020-14948, 2015691-2020-14953, 2015691-2020-14954, 2015691-2020-14955, 2015691-2020-14956, 2015691-2020-14957, AND 2015691-2020-14958.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF NINE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED ¿ EDWARDS SAPIEN TRANSCATHETER HEART VALVE ¿ PMA P110021, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE ¿ PMA P130009, OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ¿ PMA P140031. CITATION: YAP, JONATHAN JL, ET AL. "IMPACT OF CHRONIC KIDNEY DISEASE ON OUTCOMES IN TRANSCATHETER AORTIC VALVE IMPLANTATION." ANN ACAD MED SINGAPORE 49 (2020): 273-84. PATIENTS UNDERGOING THV PROCEDURES OFTEN HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. THEY MAY ALSO HAVE LIMITED CARDIAC RESERVE THAT CAN IMPAIR RECOVERY FROM THE PROCEDURE. AFTER THV PROCEDURES, PATIENTS ARE CLOSELY MONITORED, WHICH INCLUDES ASSESSMENT OF DEVICE IMPLANTS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE CARDIOVASCULAR DEATH IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS DESCRIBED 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 THE EDWARDS EUROPEAN AFFILIATE, THE ARTICLE: "IMPACT OF CHRONIC KIDNEY DISEASE ON OUTCOMES IN TRANSCATHETER AORTIC VALVE IMPLANTATION¿ WAS REVIEWED. DATA FROM 216 CONSECUTIVE PATIENTS, FROM A SINGLE TERTIARY CARDIAC CENTER, FROM OCTOBER 2009 TO AUGUST 2017, WITH SEVERE SYMPTOMATIC AS, WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING SELF-EXPANDABLE VALVES AND BALLOON EXPANDABLE VALVES (SAPIEN, SAPIEN XT AND SAPIEN 3). 11 REPORTED PATIENTS EXPERIENCED CARDIOVASCULAR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446301 EDWARDS TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death