BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 15433251 · Received September 15, 2022

    Report

    Report Number
    2025587-2022-02560
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    January 1, 2022
    Report Date
    September 15, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LIU K.; ET AL. TRANSAPICAL MITRAL VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHETIC VALVE USING THE J-VALVE SYSTEM WITH LOCATOR DEVICE: EARLY AND MID-TERM OUTCOMES. ANN TRANSL MED 2022 JAN 07;10(1):21. PMID: (B)(4). DOI: 10.21037/ATM-21-6513. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II PORCINE MITRAL VALVE (PMA# P980043, PRODUCT CODE: DYE). 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 REGARDING THE SAFETY AND EFFECTIVENESS OF IMPLANTING A 2ND-GENERATION SELF-EXPANDABLE TRANSCATHETER VALVE THROUGH THE TRANSAPICAL ROUTE. ALL DATA WERE COLLECTED FROM A SINGLE CHINESE MEDICAL CENTER BETWEEN JANUARY 2019 AND DECEMBER 2020. THE STUDY POPULATION INCLUDED 19 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 70 YEARS. THE PATIENTS HAD PREVIOUSLY UNDERGONE TRANSCATHETER OR SURGICAL IMPLANTATION OF BIOPROSTHETIC MITRAL VALVES INVOLVING MULTIPLE MANUFACTURER¿S DEVICES. NINE PATIENTS WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC HANCOCK II PORCINE MITRAL VALVE APPROXIMATELY 9-14 YEARS PRIOR TO REQUIRING ANOTHER MITRAL VALVE REPLACEMENT. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL MEDTRONIC HANCOCK II PATIENTS, ADVERSE EVENTS INCLUDED: DEGENERATED VALVES RESULTING IN MITRAL STENOSIS AND MITRAL REGURGITATION, REQUIRING HOSPITALIZATION AND TRANSCATHETER MITRAL VALVE REPLACEMENT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS 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
    1651856 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R