BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 8633224 · Received May 22, 2019

    Report

    Report Number
    3004478276-2019-00166
    Event Type
    Injury
    Date Received
    May 22, 2019
    Report Date
    October 30, 2019
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019 THE MANUFACTURER RECEIVED COMMUNICATION BETWEEN THE PHYSICIANS INVOLVED, PROFESSOR (B)(6) AND PROFESSOR (B)(6). THE PHYSICIANS HAVE STATED THEY ARE NOT AWARE OF ANY MITROFLOW DEVICE RELATED VALVE-IN-VALVE EVENTS WITHIN THE SPECIFIED TIME PERIOD. THEY REPORTED THERE WAS A TAVI PERFORMED IN A PERIMOUNT VALVE AND THAT IS THE ONLY EVENT WHICH OCCURRED. PROFESSOR (B)(6): "LK BEN NOG AAN T UITZOEKEN HOE HET ZIT WANT DE ENIGE VALVE IN VALVE DIE WE IN DIE PERIODE HEBBEN GEDAAN WAS IN EEN PERIMOUNT." BASED ON THE INFORMATION RECEIVED THERE IS NO REASON TO BELIEVE THERE WAS A COMPLAINT INVOLVING A LIVANOVA PRODUCT, GIVEN THE CURRENT INFORMATION AVAILABLE. GIVEN THIS THE MANUFACTURER WILL PROCEED WITH THE CLOSURE OF THIS CASE WITH NO FURTHER INVESTIGATION. IF THE MANUFACTURER RECEIVES ADDITIONAL INFORMATION IDENTIFYING A RELATIONSHIP BETWEEN THE REPORTED VALVE-IN-VALVE PROCEDURE AND A LIVANOVA PRODUCT THE MANUFACTURER WILL REASSESS THE CASE AND PERFORM ANY NECESSARY INVESTIGATIONS. FIELDS CHANGED: B4, G4, G7, H2, H6.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: NOT EXPLANTED.

    Description of Event or Problem · 1

    A PATIENT UNDERGOING AORTIC VALVE REPLACEMENT RECEIVED A MITROFLOW AORTIC BIOPROSTHESIS (MODEL UNKNOWN). A VALVE-IN-VALVE WAS PERFORMED IN (B)(6) 2018 DUE TO STRUCTURAL VALVE DETERIORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424342 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention