BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4193341 · Received October 22, 2014

    Report

    Report Number
    2025587-2014-00783
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED POSTAL CODE FOR MANUFACTURER. IT WAS INADVERTANTLY LEFT OFF OF THE ORIGINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ELECTROCARDIOGRAM (ECG) REVEALED LEFT BUNDLE BRANCH BLOCK (LBBB). SUBSEQUENTLY, THE SAME DAY, A PERMANENT PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673059 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P4-23-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention