BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9036485 · Received September 13, 2019

    Report

    Report Number
    2025587-2019-02817
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    June 12, 2019
    Report Date
    September 13, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JOCHHEIM D ET AL. ORAL ANTICOAGULANT TYPE AND OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2019 AUG 26;12(16):1566-1576. DOI: 10.1016/J.JCIN.2019.03.003. EPUB 2019 JUN 12. 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. ADDITIONAL PATIENT CODE(S): (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 IMPACT OF ORAL ANTICOAGULATION TYPE ON CLINICAL OUTCOMES IN PATIENTS AT 1-YEAR POST-TRANSCATHETER AORTIC VALVE REPLACEMENT. CLINICAL OUTCOMES WERE DEFINED ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM-2 (VARC-2) CRITERIA AND BLEEDING COMPLICATIONS WERE DEFINED ACCORDING TO BLEEDING ACADEMIC RESEARCH CONSORTIUM (BARC) CRITERIA. ALL DATA WERE COLLECTED FROM 4 CENTERS BETWEEN JUNE 2007 AND FEBRUARY 2017. THE STUDY POPULATION INCLUDED 962 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS), 234 WERE IMPLANTED WITH MEDTRONIC COREVALVE (167) OR EVOLUT R (67) BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 155 DEATHS OCCURRED WITHIN 1-YEAR POST IMPLANT. OF THESE, 38 WERE DUE TO CARDIO-CEREBROVASCULAR CAUSES AND 4 WERE DUE TO FATAL BLEEDING. THE MANUFACTURER(S) OF THE TRANSCATHETER VALVES USED TO TREAT THESE 42 PATIENTS WAS NOT REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, THE PROCEDURAL/PERI-PROCEDURAL ADVERSE EVENTS INCLUDED: MAJOR VARC-2 VASCULAR COMPLICATIONS (NO OTHER DETAILS WERE PROVIDED), VALVE DISLOCATION, AND REGURGITATION (GREATER THAN OR EQUAL TO GRADE 2). THE ADVERSE EVENTS THAT OCCURRED WITHIN 30 DAYS AND 1-YEAR POST IMPLANT INCLUDED: CEREBROVASCULAR EVENTS (DISABLING STROKE, NON-DISABLING STROKE, OR TRANSIENT ISCHEMIC ATTACK), MYOCARDIAL INFARCTION, MAJOR OR LIFE-THREATENING BLEEDING, AND VALVE THROMBOSIS (4 CASES REPORTED AT 1-YEAR FOLLOW-UP). 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
    816455 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| S