BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8465041 · Received March 29, 2019

    Report

    Report Number
    2025587-2019-01067
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    February 10, 2019
    Report Date
    March 29, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WANG TY ET AL. "GENDER DISPARITIES IN MANAGEMENT AND OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH NEWER GENERATION TRANSCATHETER VALVES." AM J CARDIOL. 2019 FEB 10. PII: S0002-9149 (19) 30179-1. DOI: 10.1016/J.AMJCARD.2019.01.048. [EPUB AHEAD OF PRINT]. 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 THE 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 AN EVALUATION OF GENDER-SPECIFIC DIFFERENCES IN PROCEDURAL MANAGEMENT AND CLINICAL OUTCOMES IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH NEWER GENERATION TRANSCATHETER HEART VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN DECEMBER 2015 AND JUNE 2018. THE STUDY POPULATION INCLUDED 298 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 80 YEARS; MEAN WEIGHT 80 KG), 65 OF WHICH WERE EITHER IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE OR A MEDTRONIC EVOLUT PRO BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, THE IN-HOSPITAL ALL-CAUSE MORTALITY RATE WAS 1.3% FOR MALE PATIENTS AND 1.4% FOR FEMALE PATIENTS, RESPECTIVELY. BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION AND DISABLING STROKE. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258251 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention