BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9731125 · Received February 20, 2020

    Report

    Report Number
    2025587-2020-00521
    Event Type
    Death
    Date Received
    February 20, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 26, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017668
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEATH OCCURRED FOLLOWING THE VALVE IMPLANT DUE TO HYPOTENSION THAT OCCURRED DESPITE VASOPRESSOR, INOTROPIC AND FLUID CHALLENGE. A DUAL CHAMBER PACEMAKER WAS IMPLANTED DUE TO BRADYCARDIA AND A LEFT VENTRICULAR ASSIST DEVICE WAS PLACED PRIOR TO THE DEATH. PER THE PHYSICIAN THE BRADYCARDIA AND DEATH WERE NOT RELATED TO THE DEVICE OR THE VALVE IMPLANT PROCEDURE. NO AUTOPSY WAS PERFORMED. CORRECTED DATA: MEDTRONIC BECAME AWARE OF THE DEATH ON JANUARY 22, 2020 AND NOT JANUARY 20, 2020 AS WAS REPORTED ON THE INITIAL MEDWATCH REPORT SUBMITTED FEBRUARY 19, 2020. THE ADDITIONAL INFORMATION WHICH INDICATED THE EVENT WAS UNRELATED TO THE DEVICE AND PROCEDURE WAS RECEIVED ON FEBRUARY 25, 2020. H8 - USAGE OF DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197489 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26-US 00763000017668

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death