BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3953368 · Received July 23, 2014

    Report

    Report Number
    2025587-2014-00519
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 12, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW IS NOT REQUIRED AS THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF THE PAV. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT COMPLETE HEART BLOCK WAS OBSERVED FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE. A PERMANENT PACEMAKER WAS IMPLANTED THE FOLLOWING DAY. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431498 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention