BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7045339 · Received November 20, 2017

    Report

    Report Number
    2025587-2017-02198
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 14, 2015
    Report Date
    November 20, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MUNERETTO, C. MD ET AL. TREATING THE PATIENTS IN THE ¿GREY-ZONE¿ WITH AORTIC VALVE DISEASE: A COMPARISON AMONG CONVENTIONAL SURGERY, SUTURELESS VALVES AND TRANSCATHETER AORTIC VALVE REPLACEMENT. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 20 (2015) 90¿95 DOI 10.1093/ICVTS/IVU340. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (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 REVIEW REGARDING TREATMENT OPTION IN PATIENTS WITH AN INTERMEDIATE- TO HIGH SURGICAL RISK. ALL DATA WERE COLLECTED BETWEEN 2010 AND 2013. THE STUDY POPULATION INCLUDED 163 PATIENTS, 55 WHICH WERE IMPLANTED WITH A COREVALVE. THE COREVALVE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 81 ± 6 YEARS. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), LEFT BUNDLE BRANCH BLOCK (LBBB), COMPLETE HEART BLOCK (CHB), PERMANENT PACEMAKER IMPLANT, VASCULAR COMPLICATIONS, ATRIAL FIBRILLATION (AFIB), MYOCARDIAL INFARCTION (MI), CARDIAC TAMPONADE, HYPOTENSION AND USE OF AN INTRA-AORTIC BALLOON PUMP, MILD OR GREATER AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823548 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