BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9296817 · Received November 8, 2019

    Report

    Report Number
    2015691-2019-04153
    Event Type
    Death
    Date Received
    November 8, 2019
    Date of Event
    November 1, 2008
    Report Date
    October 15, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  PLEASE REFERENCE RELATED MANUFACTURER REPORT NO:   2015691-2019-04152, 2015691-2019-04153, 2015691-2019-04154, 2015691-2019-04155, 2015691-2019-04156.

    Additional Manufacturer Narrative · 1

    REFERENCE CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.  THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM NOVEMBER 2008 TO PUBLISH DATE NOVEMBER 2012. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD ((B)(6) 2008) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, 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.  REFERENCE ARTICLE: WILBRING, MANUEL, ET AL. "TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION VS CONVENTIONAL AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH PREVIOUS CARDIAC SURGERY: A PROPENSITY-SCORE ANALYSIS." EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 44.1 (2013): 42-47. 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.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS AFFILIATE IN (B)(6) THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION VS CONVENTIONAL AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH PREVIOUS CARDIAC SURGERY: A PROPENSITY-SCORE ANALYSIS¿ REGARDING A GROUP OF PATIENTS WHO UNDERWENT TAVI WITH AN EDWARDS SAPIEN VALVE BY TA APPROACH, THE FOLLOWING IN-HOSPITAL POST-OPERATIVE COMPLICATION WAS OBSERVED: TWO PATIENTS DIED FROM ELECTROMECHANICAL DISSOCIATION DURING THE FIRST 30 POSTOPERATIVE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090280 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| L