BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 7522168 · Received May 17, 2018

    Report

    Report Number
    2025587-2018-01159
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    October 1, 2002
    Report Date
    May 17, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BACH. D., IMPACT OF IMPLANT TECHNIQUE FOLLOWING FREESTYLE STENTLESS AORTIC VALVE REPLACEMENT, THE ANNALS OF THORACIC SURGERY, (B)(6) 2002; 74(4): 1107-1114DOI-10.1016/S0003-4975(02)03832-8. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 IMPACT OF IMPLANT TECHNIQUE FOLLOWING FREESTYLE STENTLESS AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS FROM AUGUST 1992. THE STUDY POPULATION INCLUDED 662 PATIENTS (PREDOMINANTLY MALE). ALL OF THEM WERE IMPLANTED WITH 19 MM, 21 MM, 23 MM, 25 MM AND 27 MM MEDTRONIC FREESTYLE VALVE. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE AORTIC REGURGITATION (AR) AND REOPERATION FOR AN UNSPECIFIED CAUSE. BASED ON TH E AVAILABLE INFORMATION, A DIRECT CORRELATION WAS LIKELY BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363604 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention