BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 10905745 · Received November 25, 2020

    Report

    Report Number
    2015691-2020-14708
    Event Type
    Death
    Date Received
    November 25, 2020
    Date of Event
    December 1, 2015
    Report Date
    November 6, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14703, 2015691-2020-14704, 2015691-2020-14705, 2015691-2020-14706, 2015691-2020-14707, (B)(4), 2015691-2020-14709, 2015691-2020-14710.

    Additional Manufacturer Narrative · 1

    THIS IS SIX OF EIGHT MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM DECEMBER 2015 TO DECEMBER 2018. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-DECEMBER-2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS BRAND NAME AND MODEL # OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVES ARE:¿ P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT" TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AND EDWARDS SAPIEN 3 ULTRA HEART VALVE. PLEASE REFERENCE ARTICLE: UCHIDA, YASUHIRO, ET AL. "IMPACT OF SKELETAL MUSCLE MASS ON CLINICAL OUTCOMES IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT." CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (2020): 1-9. IN THIS CASE THE CAUSE OF DEATH IS UNKNOWN; HOWEVER, IT COULD BE RELATED TO THE PATIENT FACTORS AND PROCEDURAL FACTORS NOT PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A RELATIONSHIP EXISTED BETWEEN THE PATIENTS DEATH AND THE IMPLANTED VALVE. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. 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. DEATH IS LISTED IN THE INSTRUCTIONS FOR USE FOR THE TAVR PROCEDURE AND ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH THE PROCEDURE. THERE IS NO ALLEGATION OF AN EDWARDS DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. 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

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN JAPAN THROUGH REVIEW OF ARTICLE IMPACT OF SKELETAL MUSCLE MASS ON CLINICAL OUTCOMES IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT REGARDING A¿ SINGLE-CENTER STUDY CONDUCTED ON 71 CONSECUTIVE PATIENTS WHO UNDERWENT TAVR FOR SYMPTOMATIC SEVERE AORTIC STENOSIS FROM DECEMBER 2015 TO DECEMBER 2018. THE FOLLOWING CLINICAL OUTCOMES WERE NOTE IN TABLE 3: DURING THE POSTOPERATIVE PERIOD 3 PATIENTS EXPIRED DUE TO CARDIOVASCULAR¿DEATHS. DETAILS OF THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370632 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death