BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9527669 · Received December 27, 2019

    Report

    Report Number
    2025587-2019-03903
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    September 9, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ORVIN K ET AL. LONG-TERM FUNCTIONAL AND STRUCTURAL DURABILITY OF BIOPROSTHETIC VALVES PLACED IN THE AORTIC VALVE POSITION VIA PERCUTANEOUS ROUT IN ISRAEL. AM J CARDIOL. 2019 DEC 1;124(11):1748-1756. DOI: 10.1016/J.AMJCARD.2019.08.043. EPUB 2019 SEP 9. 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 CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). 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 LONG-TERM FUNCTIONAL AND STRUCTURAL VALVE DURABILITY IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH EITHER SELF-EXPANDABLE OR BALLOON-EXPANDABLE VALVES. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM 3 CENTERS BETWEEN APRIL 2008 AND DECEMBER 2011. THE STUDY POPULATION INCLUDED 450 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS. OF THOSE, 310 WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 236 DEATHS OCCURRED DURING THE 5-YEAR FOLLOW-UP PERIOD. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VALVE MALPOSITION THAT REQUIRED SECOND VALVE IMPLANTATION, STRUCTURAL VALVE DETERIORATION THAT REQUIRED AORTIC VALVE REINTERVENTION, VALVE MIGRATION, MILD-MODERATE-SEVERE PARAVALVULAR AND/OR INTRAVALVULAR LEAK, MILD-MOD ERATE-SEVERE MITRAL REGURGITATION, RUPTURED VALVE, THICKENED VALVE LEAFLETS, AND INCREASED PEAK/MEAN TRANSVALVULAR GRADIENTS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321368 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention