BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9578629 · Received January 10, 2020

    Report

    Report Number
    2025587-2020-00141
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    March 11, 2019
    Report Date
    January 10, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YEHYA A ET AL. SHORT-TERM RESULTS WITH TRANSCATHETER AORTIC VALVE REPLACEMENT FOR TREATMENT OF LEFT VENTRICULAR ASSIST DEVICE PATIENTS WITH SYMPTOMATIC AORTIC INSUFFICIENCY. JOURNAL OF HEART AND LUNG TRANSPLANTATION. 2019; 38:920-926. DOI: 10.1016/J. HEALUN.2019.03.001. 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. 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 SHORT-TERM RESULTS OF PATIENTS RECEIVING A TRANSCATHETER AORTIC VALVE REPLACEMENT FOLLOWING THE IMPLANT OF A LEFT VENTRICULAR ASSIST DEVICE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN OCTOBER 2010 AND AUGUST 2017. THE STUDY POPULATION INCLUDED 286 PATIENTS, 9 OF WHICH (PREDOMINANTLY MALE, MEDIAN AGE 51 YEARS) WERE IMPLANTED WITH MEDTRONIC COREVALVE OR EVOLUT R (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC COREVALVE AND EVOLUT R PATIENTS, 4 DEATHS OCCURRED BETWEEN 1 MONTH AND 1 YEAR POST IMPLANT OF THE TRANSCATHETER VALVE. ONE PATIENT DIED AT 4 MONTHS POST IMPLANT DUE TO CARDIAC ARREST. THE OTHER DEATHS OCCURRED BETWEEN 6 MONTHS AND 1 YEAR POST IMPLANT OF THE TRANSCATHETER VALVE DUE TO HEMORRHAGIC CEREBROVASCULAR ACCIDENT OR MULTISYSTEM ORGAN FAILURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC COREVALVE PATIENTS, ADVERSE EVENTS INCLUDED: VALVE MIGRATION REQUIRING A VALVE-IN-VALVE PROCEDURE, HEMATOMA, PSE UDOANEURYSM, AND MODERATE PARAVALVULAR LEAK. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    37541 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention