BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8606369 · Received May 13, 2019

    Report

    Report Number
    2025587-2019-01569
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    January 28, 2019
    Report Date
    May 13, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SUN Y ET AL. "OUTCOMES OF EVOLUT R VERSUS COREVALVE AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION: A META-ANALYSIS." HEART LUNG CIRC. 2019 JAN 28. PII: S1443-9506 (19)30035-6. DOI: 10.1016/J.HLC.2018.12.013. EARLIEST DATE OF PUBLICATION 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 A META-ANALYSIS COMPARISON OF THE OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE MEDTRONIC EVOLUT R VERSUS THE MEDTRONIC COREVALVE. ALL DATA WERE COLLECTED FROM A SEARCH OF THE PUBMED, EMBASE AND COCHRANE LIBRARY DATABASES. THE SYSTEMATIC REVIEW COMPRISED SIX STUDIES WITH INCLUSION PERIODS BETWEEN 2007 AND 2016. THE STUDY POPULATION INCLUDED 11,530 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 4 ,597 OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES AND 6,933 WERE IMPLANTED WITH COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, THE 30-DAY ALL-CAUSE MORTALITY RATE WAS 3.4% FOR EVOLUT R RECIPIENTS AND 5.0% FOR COREVALVE RECIPIENTS, RESPECTIVELY. PROCEDURAL MORTALITY WAS DISCUSSED; HOWEVER, CAUSES OF DEATH WERE NOT REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, MYOCARDIAL INFARCTION, STROKE, TRANSIENT ISCHEMIC ATTACK, MODERATE-SEVERE PARAVALVULAR REGURGITATION, INCORRECT VALVE POSITIONING, SEVERE BLEEDING (LIFE-THREATENING OR MAJOR BLEEDING), AND MAJOR VASCULAR COMPLICATIONS. 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
    398656 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention