BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL MECHANICAL VALVE

    MDR report key: 12554823 · Received September 30, 2021

    Report

    Report Number
    2025587-2021-02927
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    February 10, 2021
    Report Date
    September 30, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SICIM H, ET AL. COMPARISON OF POSTOPERATIVE OUTCOMES BETWEEN ROBOTIC MITRAL VALVE REPLACEMENT AND CONVENTIONAL MITRAL VALVE REPLACEMENT. J CARD SURG. 2021 APR;36(4):1411-1418. DOI: 10.1111/JOCS.15418. EPUB 2021 FEB 10. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS THAT MAY HAVE BEEN USED: MED HALL (PMA# P790018, PRODUCT CODE LWQ), OPEN PIVOT (PMA# P990046, PRODUCT CODE LWQ). 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 FROM A LITERATURE ARTICLE REGARDING THE PATIENT OUTCOMES FOLLOWING ROBOTIC MITRAL VALVE REPLACEMENT COMPARED TO CONVENTIONAL STERNOTOMY. ALL DATA WAS RETROSPECTIVELY ANALYZED FROM A SINGLE CENTER BETWEEN 2014 AND 2020. THE STUDY POPULATION INCLUDED 130 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 57.4 YEARS) WHO UNDERWENT ROBOTIC OR CONVENTIONAL MITRAL VALVE REPLACEMENT. THE AUTHORS WROTE, ¿ST. JUDE MEDICAL (MEDTRONIC) MECHANICAL HEART VALVES WERE USED FOR REPLACEMENT¿. SINCE ST. JUDE MEDICAL AND MEDTRONIC ARE TWO SEPARATE DEVICE MANUFACTURERS, IT IS UNKNOWN WHETHER ST. JUDE OR MEDTRONIC MECHANICAL HEART VALVES WERE IMPLANTED IN THE PATIENT POPULATION. NO BRAND NAMES OR UNIQUE DEVICE IDENTIFIER NUMBERS WERE DISCLOSED. AMONG ALL PATIENTS, FOUR POST-OPERATIVE DEATHS OCCURRED. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS THAT OCCURRED DURING THE POST-OPERATIVE PERIOD (BETWEEN THE IMPLANT PROCEDURE AND HOSPITAL DISCHARGE) INCLUDED: REVISION FOR BLEEDING; STROKE/NEUROLOGICAL COMPLICATIONS; WOUND INFECTION (SURGICAL INTERVENTION NOT REQUIRED); AND ARRHYTHMIA (RHYTHM RESTORED WITH MEDICATION OR CARDIOVERSION). 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
    1453210 MEDTRONIC SURGICAL MECHANICAL VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION MDT-MECH VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R