BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12847531 · Received November 19, 2021

    Report

    Report Number
    2025587-2021-03515
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    May 20, 2021
    Report Date
    November 19, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GUPTA ET AL. PATIENT-PROSTHESIS MISMATCH AND SURGICAL AORTIC VALVE REPLACEMENT OUTCOMES: RETROSPECTIVE ANALYSIS OF SINGLE-CENTER SURGICAL DATA. J CARD SURG. 2021 AUG;36(8):2805-2815. DOI: 10.1111/JOCS.15658. EPUB 2021 MAY 20. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR), MOSAIC (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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A RETROSPECTIVE ANALYSIS OF PATIENT-PROSTHESIS MISMATCH AND SURGICAL AORTIC VALVE REPLACEMENT OUTCOMES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER FROM 2006 THRU THE END OF 2016. THE STUDY POPULATION INCLUDED 3,003 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 68 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, AN UNSPECIFIED NUMBER WERE IMPLANTED WITH A MEDTRONIC FREESTYLE AORTIC ROOT, MOSAIC BIOPROSTHETIC VALVE, OR HALL MECHANICAL VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 161 TOTAL DEATHS OCCURRED: 12 INTRAOPERATIVE AND 149 IN-HOSPITAL. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PATIENT-PROSTHESIS MISMATCH (PPM), AORTIC STENOSIS, AORTIC INSUFFICIENCY, AND REOPERATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744756 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| L| H