BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 15090186 · Received July 23, 2022

    Report

    Report Number
    2025587-2022-02083
    Event Type
    Injury
    Date Received
    July 23, 2022
    Date of Event
    February 13, 2021
    Report Date
    July 23, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: THANDRA A.; ET AL. VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS REDO SURGICAL VALVE REPLACEMENT FOR DEGENERATED BIOPROSTHETIC AORTIC VALVE: AN UPDATED META-ANALYSIS COMPARING MIDTERM OUTCOMES. CATHETER CARDIOVASC INTERV. 2021 JUN 1;97(7):1481-1488. DOI: 10.1002/CCD.29541. PMID: (B)(4). EPUB 2021 FEB 13 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK (PMA# P870078, PRODUCT CODE: DYE); (PMA# P990064, PRODUCT CODE: DYE); COREVALVE (PMA# P130021, PRODUCT CODE: NPT); ENGAGER (PMA# N/A, PRODUCT CODE: N/A). (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 VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV TAVR) VERSUS RE-DO SURGICAL AORTIC VALVE REPLACEMENT (SAVR) FOR BIOPROSTHETIC VALVE DEGENERATION. ALL DATA WERE COLLECTED FROM A META-ANALYSIS LITERATURE REVIEW OF MULTIPLE DATABASES FROM INCEPTION THROUGH AUGUST 2020. NINE OBSERVATIONAL STUDIES WERE ANALYZED, COMPRISING A COMBINED POPULATION OF 2,891 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 75 YEARS. THE VIV TAVR GROUP INVOLVED 1,395 PATIENTS AND THE RE-DO SAVR GROUP INVOLVED 1,496 PATIENTS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, IMPLANTS INVOLVED SEVERAL MEDTRONIC MODELS, INCLUDING HANCOCK AND MOSAIC SURGICAL BIOPROSTHETIC VALVES AND COREVALVE AND ENGAGER TRANSCATHETER BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, CUMULATIVE MORTALITY (MEAN FOLLOW-UP OF 26 MONTHS) WAS 22% IN THE VIV GROUP AND 19.6% IN THE RE-DO SAVR GROUP. NO FURTHER INFORMATION WAS PROVIDED ON THE NATURE/CAUSES OF THESE DEATHS IN THE META-ANALYSIS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BIOPROSTHETIC VALVE DEGENERATION, LEADING TO AORTIC STENOSIS AND/OR AORTIC REGURGITATION, REQUIRING VIV TAVR OR RE-DO SAVR TO RESOLVE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    87230 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown