BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7359556 · Received March 21, 2018

    Report

    Report Number
    2025587-2018-00651
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 21, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SANGHVI K, OSTIAL LEFT MAIN OCCLUSION FOLLOWING SURGICAL AORTIC VALVE REPLACEMENT (SAVR) J CARD SURG. (B)(6) 2018. DOI: 10. 1111/JOCS.13551. 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 A (B)(6) FEMALE WITH MEDICAL HISTORY OF BICUSPID AORTIC VALVE AND SEVERE AORTIC STENOSIS WHO UNDERWENT A SURGICAL AORTIC VALVE REPLACEMENT WITH A 19-MM MEDTRONIC MOSAIC BIOPROSTHESIS (SERIAL NUMBER NOT PROVIDED). POST-IMPLANT, TOTAL OCCLUSION OF LEFT MAIN CORONARY ARTERY (LMCA) AND HYPOTENSION WAS REPORTED. THE LMCA WAS STENTED WITH NON-MEDTRONIC BARE METAL RENAL STENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202344 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention