BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL MECHANICAL VALVE

    MDR report key: 10687800 · Received October 15, 2020

    Report

    Report Number
    2025587-2020-03127
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    April 19, 2020
    Report Date
    October 15, 2020
    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: GUNER A ET AL. COMPARISON OF DIFFERENT ANTICOAGULATION REGIMENS REGARDING MATERNAL AND FETAL OUTCOMES IN PREGNANT PATIENTS WITH MECHANICAL PROSTHETIC HEART VALVES (FROM THE MULTICENTER ANATOLIA-PREG REGISTRY). AMERICAN JOURNAL OF CARDIOLOGY. 2020; 127(ISSUE):113-119. DOI: 10.1016/J.AMJCARD.2020.04.010. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MEDHALL MECHANICAL HEART VALVE (PMA# P790018, PRODUCT CODE LWQ), OPEN PIVOT MECHANICAL HEART VALVE (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 VIA LITERATURE REGARDING THE MATERNAL AND FETAL OUTCOMES OF PATIENTS WITH MECHANICAL HEART VALVES AND UNDERGOING VARIOUS ANTICOAGULATION REGIMENS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 1996 AND AUGUST 2019. THE STUDY POPULATION INCLUDED 110 PATIENTS (ENTIRELY FEMALE, MEAN AGE 30 YEARS, A TOTAL OF 155 PREGNANCIES), AN UNKNOWN NUMBER OF WHOM WERE IMPLANTED WITH A MEDTRONIC MEDHALL OR ATS (OPEN PIVOT) MECHANICAL VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 2 MATERNAL DEATHS OCCURRED. ONE PATIENT WHO WAS ON A REGIMEN OF LOW MOLECULAR WEIGHT HEPARIN (FIRST TRIMESTER) AND WARFARIN (SECOND AND THIRD TRIMESTER) SUFFERED FROM A HEMORRHAGIC CEREBROVASCULAR EVENT AND OBSTRUCTIVE PROSTHETIC VALVE THROMBOSIS. THE OTHER PATIENT WHO WAS ON A REGIMEN OF LOW MOLECULAR WEIGHT HEPARIN THROUGHOUT THE PREGNANCY DIED FROM AN ISCHEMIC CEREBROVASCULAR EVENT AND DISSEMINATED INTRAVASCULAR COAGULATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, AND THERE WAS NO ASSOCIATION BETWEEN THE DEATHS AND THE HEART VALVES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: FETAL LOSS (STILLBIRTH, MISCARRIAGE, OR ABORTION), PRETERM BIRTH, CONGENITAL ANOMALY, THROMBOSIS, CEREBROVASCULAR EVENTS, TRANSIENT ISCHEMIC ATTACK, THROMBOEMBOLIC COMPLICATIONS, INFECTIVE ENDOCARDITIS, PREECLAMPSIA/ECLAMPSIA, MAJOR BLEEDING, HYSTERECTOMY, PARAVALVULAR LEAK, PANNUS FORMATION. 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
    1152171 MEDTRONIC SURGICAL MECHANICAL VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION MDT-MECH VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Congenital Anomaly| H| L| R