BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12393092 · Received August 31, 2021

    Report

    Report Number
    2025587-2021-02701
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    January 4, 2021
    Report Date
    August 31, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LIU P ET AL. WHICH IS THE BEST PROSTHESIS IN AN ISOLATED OR COMBINED TRICUSPID VALVE REPLACEMENT? EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2021; 59:170-179. DOI: 10.1093/EJCTS/EZAA273. MEDTRONIC PRODUCTS REFERENCED: MOSAIC BIOPROSTHETIC VALVE (PMA# P980043, PRODUCT CODE DYE), HANCOCK II BIOPROSTHETIC VALVE (PMA# P990064, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A RETROSPECTIVE COMPARISON OF OUTCOMES OF PATIENTS UNDERGOING A TRICUSPID VALVE REPLACEMENT WITH A BIOPROSTHETIC OR MECHANICAL VALVE, WITH OR WITHOUT A CONCOMITANT SURGERY ON THE LEFT SIDE OF THE HEART. ALL DATA WERE COLLECTED FROM TWO CENTERS BETWEEN JANUARY 1999 AND DECEMBER 2018. THE STUDY POPULATION INCLUDED 338 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 41.3 YEARS), 43 OF WHOM WERE IMPLANTED WITH MEDTRONIC MOSAIC BIOPROSTHETIC VALVE AND 72 OF WHOM WERE IMPLANTED WITH MEDTRONIC HANCOCK II BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 9 DEATHS OCCURRED WITHIN 30 DAYS OF IMPLANT DUE TO CARDIAC FAILURE RELATED TO SEVERE DEPRESSION OF MYOCARDIAL FUNCTION. THROUGHOUT THE FOLLOW-UP PERIOD, 91 OTHER PATIENTS DIED DUE TO CARDIAC REASONS (58 PATIENTS), LOW CARDIAC OUTPUT SYNDROME (21 PATIENTS), VALVE-RELATED COMPLICATIONS (37 PATIENTS), AND NON-CARDIAC REASONS (33 PATIENTS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION, AND NO ASSOCIATION WAS MADE BETWEEN THE DEATHS AND A SPECIFIC MANUFACTURER¿S DEVICES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: RIGHT-SIDED HEART FAILURE, LIVER FAILURE, RENAL FAILURE, INFECTION, BLEEDING, COMPLETE HEART BLOCK REQUIRING A PERMANENT PACEMAKER, CEREBROVASCULAR ACCIDENT, PULMONARY HYPERTENSION, THROMBOSIS, STRUCTURAL VALVE DETERIORATION, SEVERE TRICUSPID REGURGITATION, PANNUS FORMATION, ENDOCARDITIS. 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
    1295017 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R