BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3F AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6520702 · Received April 25, 2017

    Report

    Report Number
    2025587-2017-00670
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 9, 2017
    Manufacturer
    MEDTRONIC 3F THERAPEUTICS, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: INITIAL EXPERIENCE WITH AORTIC VALVE REPLACEMENT VIA A MINIMALLY INVASIVE APPROACH: A COMPARISON OF STENTED, STENTLESS AND SUTURELESS VALVES CITATION: MEDICAL SCIENCE MONITOR (2017) 23:1645-1654 (DOI 10.12659/MSM.901780) AUTHORS: KONERTZ, JOHANNA ET AL. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE RESULTS AFTER MINIMALLY INVASIVE STENTED, STENTLESS AND SUTURELESS VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2010 AND JUNE 2015. THE STUDY POPULATION INCLUDED 79 PATIENTS, 27 OF WHICH WERE IMPLANTED WITH A MEDTRONIC 3F SURGICAL VALVE. THE PATIENTS IMPLANTED WITH THE MEDTRONIC DEVICE WERE PREDOMINANTLY MALE WITH A MEDIAN AGE OF 71.1 YEARS. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS IMPLANTED WITH A 3F VALVE, ADVERSE EVENTS INCLUDED: ATRIAL FIBRILLATION (AFIB) TREATED WITH MEDICATION, ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH A PERMANENT PACEMAKER IMPLANT, INCREASED GRADIENT MEASUREMENTS, MILD REGURGITATION AND BLEEDING TREATED WITH RE-EXPLORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301909 3F AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC 3F THERAPEUTICS, INC. 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention