BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8193236 · Received December 23, 2018

    Report

    Report Number
    2025587-2018-03532
    Event Type
    Injury
    Date Received
    December 23, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 23, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GROSS, L. ET AL. PLATELET REACTIVITY AND EARLY OUTCOMES AFTER TRANSFEMORAL AORTIC VALVE IMPLANTATION. JOURNAL OF THROMBOSIS AND HAEMOSTASIS. OCT;118(10):1832-1838 EPUB 2018 SEP 20 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. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. 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 PLATELET REACTIVITY AND EARLY OUTCOMES AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A MULTIPLE CENTERS CLINICAL STUDY BETWEEN OCTOBER 2012 AND JUNE 2015. THE STUDY POPULATION INCLUDED 720 PATIENTS. PATIENT WERE IMPLANTED WITH A EITHER A COREVALVE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE, A BALLOON-EXPANDABLE OR A MECHANICALLY-EXPANDABLE NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 83 YEARS AMONG ALL PATIENTS, NONE OF THE DEATHS WERE ATTRIBUTED TO A MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA) AND VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032311 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening