BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9435056 · Received December 8, 2019

    Report

    Report Number
    2025587-2019-03697
    Event Type
    Injury
    Date Received
    December 8, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OKUNO, T. MD. ET AL. PROSTHESIS-PATIENT MISMATCH FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SUPRA-ANNULAR AND INTRA-ANNULAR PROSTHESES. JACC: CARDIOVASCULAR INTERVENTIONS. (2019) 12(21):2173-2182. DOI: 10.1016/J.JCIN.2019.07.027 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN B3. 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 PATIENT PROSTHESIS MISMATCH AFTER THE IMPLANT OF A SUPRA-ANNULAR AND INTRA-ANNULAR TRANSCATHETER AORTIC VALVE (TAV) REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER PROSPECTIVE REGISTRY BETWEEN AUGUST 2007 AND JUNE 2017. THE STUDY POPULATION INCLUDED 224 PATIENTS IMPLANTED WITH A SUPRA-ANNULAR MEDTRONIC COREVALVE OR EVOLUTR TAV AND 224 PATIENTS IMPLANTED WITH A NON-MEDTRONIC INTRA-ANNULAR TAV. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE, MEAN AGE 82.9 YEARS. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, NO DEATHS WERE ASSOCIATED WITH A MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATIONS/BLEEDING, VALVE-IN-VALVE, VALVE DISLODGEMENT, MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA), PERMANENT PACEMAKER IMPLANT, PATIENT PROSTHESIS MISMATCH AND MODERATE TO SEVERE AORTIC REGURGITATION. BASED ON THE AVAILABLE INFORMATION, A 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
    1229824 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention