BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8368483 · Received February 25, 2019

    Report

    Report Number
    2025587-2019-00715
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    June 22, 2017
    Report Date
    February 25, 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: SEEGER J ET AL. NEW GENERATION DEVICES FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT ARE SUPERIOR COMPARED WITH LAST GENERATION DEVICES WITH RESPECT TO VARC-2 OUTCOME. CARDIOVASC INTERV THER. 2018 JUL;33(3):247-255. DOI: 10.1007/S12928-017-0477-6. EPUB 2017 JUN 22. 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. (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 AN EVALUATION OF THE PROCEDURAL, 30-DAY AND 12-MONTH OUTCOMES ASSOCIATED WITH THE EARLY GENERATION TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) DEVICES COMPARED TO THE NEW GENERATION TAVR DEVICES IN A LARGE PATIENT COHORT UNDERGOING TRANSFEMORAL TAVR. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2010 AND 2015. THE STUDY POPULATION INCLUDED 400 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS), 100 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 2 PROCEDURAL DEATHS OCCURRED. AMONG ALL COREVALVE PATIENTS, THE 30-DAY ALL-CAUSE MORTALITY INCLUDED 11 DEATHS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL COREVALVE PATIENTS, ADVERSE EVENTS INCLUDED: CONVERSION TO SURGERY, PERMANENT PACEMAKER IMPLANTATION (DUE TO SECOND- OR TH IRD-DEGREE ATRIOVENTRICULAR BLOCK, LEFT BUNDLE BRANCH BLOCK OR BRADYARRHYTHMIAS), SECOND VALVE IMPLANTED, DISABLING/NON-DISABLING STROKE, MILD-MODERATE-SEVERE AORTIC REGURGITATION, LIFE-THREATENING BLEEDING, MAJOR VASCULAR COMPLICATIONS, AND MEAN GRADIENT GREATER THAN 20 MMHG. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161039 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention