BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6950375 · Received October 13, 2017

    Report

    Report Number
    2025587-2017-01843
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    January 1, 2017
    Report Date
    October 9, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: AN¿E DJORDJEVIC. TRANSCATHETER AORTIC VALVE IMPLANTATION FOR BICUSPID AORTIC VALVE STENOSIS: ACUTE AND INTERMEDIATE-TERM OUTCOMES IN A HIGH VOLUME INSTITUTION. SLOVENIAN MEDICAL JOURNAL. JAN-FEB 2017; 86 (1-2): 8-18. 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) FOR BICUSPID AORTIC VALVE STENOSIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2008 AND 2014. THE STUDY POPULATION INCLUDED 33 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 73 YEARS), 4 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), SECOND VALVE IMPLANTATION, CORONARY ARTERY OBSTRUCTION, CONVERSION TO SURGERY, APICAL BLEEDING, MALPOSITIONING DURING IMPLANT, MODERATE PATIENT-PROSTHESIS MISMATCH, CENTRAL AORTIC REGURGITATION, STROKE, MYOCARDIAL INFARCTION, AND PERMANENT PACEMAKER IMPLANTATION. 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
    729771 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention