BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 17237887 · Received June 30, 2023

    Report

    Report Number
    2025587-2023-02577
    Event Type
    Death
    Date Received
    June 30, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 30, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KUO CC, CHANG HH, LEU HB, ET AL. OUTCOMES AND HEMODYNAMIC PERFORMANCES OF TRANSCATHETER AORTIC VALVE REPLACEMENT WITH TWO GENERATIONS OF SELF-EXPANDING TRANSCATHETER AORTIC VALVES. ACTA CARDIOL SIN. 2023;39(3):449-456. DOI:10.6515/ACS.202305_39(3).20221109A EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH: MAY 01, 2023 (MONTH AND YEAR VALID). MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH THE MEDTRONIC EVOLUT R VALVE COMPARED TO THE MEDTRONIC COREVALVE. OF THE 234 PATIENTS INCLUDED IN THE STUDY POPULATION, 117 UNDERWENT TAVR WITH EVOLUT R AND 117 WITH COREVALVE. WITHIN 30 DAYS OF TAVR, THE AUTHORS OBSERVED 8 ALL-CAUSE DEATHS AND 5 CARDIOVASCULAR DEATHS, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED ABOUT ANY OF THE DEATHS. OTHER ADVERSE EVENTS THAT OCCURRED WERE DESCRIBED AS FOLLOWS: LEFT VENTRICULAR PERFORATION NECESSITATING CONVERSION TO OPEN SURGERY (ONLY OCCURRED IN COREVALVE RECIPIENTS), LIFE-THREATENING OR DISABLING BLEEDING, MAJOR VASCULAR COMPLICATIONS, CORONARY ARTERY OBSTRUCTION REQUIRING INTERVENTION, ACUTE KIDNEY INJURY INCLUDING RENAL REPLACEMENT THERAPY, NEED FOR A SECOND VALVE, STROKE (ONLY OCCURRED IN COREVALVE RECIPIENTS), NEW PERMANENT PACEMAKER IMPLANTATION, MODERATE PARAVALVULAR LEAK, AND ELEVATED PEAK PRESSURE GRADIENT (14.5 ± 7.4 MMHG). NO ADDITIONAL ADVERSE EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475827 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death