BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 16961457 · Received May 19, 2023

    Report

    Report Number
    2025587-2023-02124
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 19, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LIU Y, ET AL. TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION APPLYING A LONG PRE-CURVED SHEATH FOR PATIENTS WITH DEGENERATED BIOPROSTHETIC MITRAL VALVE. REV. CARDIOVASC. MED. 2023; 24(2): 50 HTTPS://DOI.ORG/10.31083/J.RCM2402050 A COPY OF THE ARTICLE WAS NOT ATTACHED AS DIGITAL SHARING WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PRODUCT CODE DYE, PMA# P980043), MOSAIC (PRODUCT CODE DYE, PMA# P990064). 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE EFFECTIVENESS OF LONG PRE-CURVED SHEATH TECHNIQUES IN TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION (TMVIV) PROCEDURES. OF THE 27 PATIENTS INCLUDED IN THE STUDY POPULATION, 17 WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC BIOPROSTHETIC MITRAL VALVE (HANCOCK II = 14, MOSAIC = 3). ALL PATIENTS IN THE STUDY UNDERWENT TMVIV WITH A NON-MEDTRONIC PROSTHESIS (NEWMED PRIZVALVE) FOR BIOPROSTHETIC VALVE DEGENERATION. MECHANISMS OF DEGENERATION INCLUDED: STENOSIS, REGURGITATION, AND COMBINED STENOSIS AND REGURGITATION. ADDITIONALLY, THE AUTHORS OBSERVED DECREASED LEFT VENTRICULAR EJECTION FRACTION AND HEART FAILURE SYMPTOMS IN SOME PATIENTS PRIOR TO TMVIV. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643741 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R