BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7125268 · Received December 18, 2017

    Report

    Report Number
    2025587-2017-02469
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    February 1, 2016
    Report Date
    December 18, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VAN MIEGHEM NM. CURRENT DECISION MAKING AND SHORT-TERM OUTCOME IN PATIENTS WITH DEGENERATIVE AORTIC STENOSIS: THE POOLED-ROTTERDAM- MILANO-TOULOUSE IN COLLABORATION AORTIC STENOSIS SURVEY. EUROINTERVENTION. (B)(6) 2016;11(11):E1305-13. DOI: 10.4244/EIJV11I10A253. 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. 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 SHORT-TERM OUTCOME IN PATIENTS WITH DEGENERATIVE AORTIC STENOSIS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS IN 2014. THE STUDY POPULATION INCLUDED 390 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 76 YEARS), 63 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 30-DAY MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE-SEVERE PARAVALVULAR LEAK (PVL), NEW LEFT BUNDLE BRANCH BLOCK (LBBB), NEW ATRIAL FIBRILLATION (AFIB), PERMANENT PACEMAKER IMPLANT, REPOSITIONING REQUIRED, SECOND VALVE IMPLANTED, BLEEDING AND VASCULAR COMPLICATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904525 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention