BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7519706 · Received May 16, 2018

    Report

    Report Number
    2025587-2018-01154
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    March 18, 2017
    Report Date
    May 16, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION 1: JACC, MARCH 21, 2017, VOLUME 69, ISSUE 11. PRESENTED ON (B)(6) 2017. CITATION 2: INNOVATIONS, VOLUME 12, NUMBER 45, 2017, P. S116. EARLIEST DATE OF PRESENTATION 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 THE FEASIBILITY OF PURPOSEFUL FRACTURE OF A SMALL BIOPROSTHETIC SURGICAL VALVE WITH A HIGH-PRESSURE BALLOON TO PREPARE FOR TRANSCATHETER VALVE-IN-VALVE (VIV) IMPLANT. ALL DATA WERE COLLECTED FROM SIX UNITED STATES MEDICAL CENTERS. THE STUDY POPULATION INCLUDED 12 PATIENTS (PURPOSEFUL VALVE FRACTURE PRIOR TO VIV IN 2 AND AFTER VIV IN L0 PATIENTS). TWO OF THE 12 PATIENTS HAD BEEN IMPLANTED WITH MEDTRONIC MOSAIC SURGICAL BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS WITH THE PREVIOUSLY IMPLANTED SURGICAL VALVE INCLUDED: STENOSIS AND HIGH GRADIENTS. THERE WERE NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS INVOLVING THE TRANSCATHETER VALVES. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362677 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention