BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 11946197 · Received June 7, 2021

    Report

    Report Number
    2025587-2021-01794
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 7, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: AHMED M., ET AL. VALVE-IN-VALVE TRANSCATHETER AORTIC-VALVE REPLACEMENT WITH BASILICA IN A PATIENT WITH HISTORY OF EVANS SYNDROME, HEPARIN INDUCED THROMBOCYTOPENIA AND HEMODIALYSIS. IS IT EVEN POSSIBLE? JACC, MAY 2021; 77(18):2357. DOI:10.1016/S0735-1097(21)03712-8 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. [MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE). 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 A (B)(6)-YEAR-OLD FEMALE PATIENT WITH PRIOR PSEUDOANEURYSM REPAIR, EVANS SYNDROME, HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), ANTI-PHOSPHOLIPID SYNDROME AND END-STAGE RENAL DISEASE (ESRD) WHO HAD PREVIOUSLY UNDERGONE SURGICAL AORTIC VALVE IMPLANTATION OF A 21-MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). THE MOSAIC VALVE DEGENERATED WITH THE PATIENT DEVELOPING SEVERE AORTIC STENOSIS WITH MODERATE REGURGITATION. THE PATIENT UNDERWENT MOSAIC VALVE FRACTURE FOLLOWED BY TRANSCATHETER VALVE-IN-VALVE AORTIC VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842957 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R