BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14736573 · Received June 17, 2022

    Report

    Report Number
    2025587-2022-01716
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 19, 2022
    Report Date
    June 17, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZHANG X-L.; ET AL. EARLY AND MIDTERM OUTCOMES OF TRANSCATHETER AORTIC-VALVE REPLACEMENT WITH BALLOON-EXPANDABLE VERSUS SELF-EXPANDING VALVES: A META-ANALYSIS. J CARDIOL. 2022 MAY 19; S0914-5087(22)00102-2. DOI: 10.1016/J.JJCC.2022.04.011. PMID: 35599108. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R (PMA# P130021, PRODUCT CODE: NPT). 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

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE COMPARING 30-DAY AND 1-YEAR OUTCOMES BETWEEN USE OF BALLOON-EXPANDABLE VALVES (BEV) VERSUS SELF-EXPANDING VALVES (SEV) FOR TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A LITERATURE META-ANALYSIS REVIEW OF MULTIPLE DATABASES FROM THEIR INCEPTION THROUGH FEBRUARY 13, 2020. THE META-ANALYSIS INCLUDED 15 STUDIES, COMPRISING A TOTAL OF 37,958 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 83 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, AN UNDETERMINED NUMBER WERE IMPLANTED WITH A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, EIGHT STUDIES IN THE META-ANALYSIS DOCUMENTED PATIENT DEATHS STRATIFIED AS ALL-CAUSE MORTALITY AND CARDIOVASCULAR MORTALITY, THOUGH THE NUMBER OF DEATHS WAS UNKNOWN. NO FURTHER INFORMATION WAS PRESENTED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR PERMANENT PACEMAKER IMPLANTATION (PPI), MODERATE-SEVERE PARAVALVULAR LEAKS (PVL), STROKES, MAJOR VASCULAR COMPLICATIONS/BLEEDING AND NEED FOR RE-HOSPITALIZATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189122 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H