BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8627750 · Received May 21, 2019

    Report

    Report Number
    2025587-2019-01652
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    December 27, 2017
    Report Date
    May 21, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GOLDSWEIG, A. MD ET AL. "PREDICTORS OF PATIENT RADIATION EXPOSURE DURING TRANSCATHETER AORTIC VALVE REPLACEMENT." CATHETER CARDIOVASC INTERV. 2018; 92: 768¿77. DOI: 10.1002/CCD.27452. 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 PREDICTORS OF RADIATION EXPOSURE DURING THE IMPLANT OF A TRANSCATHETER AORTIC VALVE IMPLANT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2012 AND FEBRUARY 2017. THE STUDY POPULATION INCLUDED 294 PATIENTS (PREDOMINANTLY MALE, MEDIAN AGE 83.8 YEARS, MEDIAN WEIGHT 71.9), TWO OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON MEDTRONIC BALLOON EXPANDABLE VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: UNKNOWN AORTIC INSUFFICIENCY, PERFORATION, VASCULAR COMPLICATIONS, INCREASED MEDIAN GRADIENTS, TAMPONADE AND VALVE-IN-VALVE PROCEDURE. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421332 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention