BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7080322 · Received December 4, 2017

    Report

    Report Number
    2025587-2017-02340
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    June 13, 2016
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BAGUR, R. MD ET AL. TRANSCATHETER AORTIC VALVE IMPLANTATION WITH OR WITHOUT PREIMPLANTATION BALLOON AORTIC VALVULOPLASTY: A SYSTEMATIC REVIEW AND META-ANALYSIS. J AM HEART ASSOC. (2016) JUN; 5(6): E003191 DOI 10.1161/JAHA.115.003191. 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 OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH AND WITHOUT A PREIMPLANT BALLOON AORTIC VALVULOPLASTY (BAV). ALL DATA WERE COLLECTED FROM A LITERATURE SEARCH CONDUCTED VIA MEDLINE AND EMBASE AND INCLUDED STUDIES PRIOR TO SEPTEMBER 20, 2015. SIXTEEN STUDIES WERE IDENTIFIED THAT MET SEARCH CRITERIA AND INVOLVED 1395 PATIENTS, 519 WHO WERE IMPLANTED WITH A COREVALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 81.3 YEARS AMONG ALL PATIENTS IMPLANTED WITH A COREVALVE, ADVERSE EVENTS INCLUDED: CONVERSION TO SURGERY, TRIVIAL TO SEVERE AORTIC REGURGITATION (AR), THE IMPLANT OF A SECOND VALVE, MYOCARDIAL INFARCTION (MI), PERMANENT PACEMAKER IMPLANT, CEREBRAL VASCULAR ACCIDENT (CVA)/TRANSIENT ISCHEMIC ATTACK (TIA), VASCULAR COMPLICATION/BLOOD LOSS, CARDIAC TAMPONADE AND MILD TO SEVERE PARAVALVULAR LEAK (PVL). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860939 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