BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3981527 · Received August 5, 2014

    Report

    Report Number
    2025587-2014-00544
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    November 16, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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

    PATIENT DEMOGRAPHICS WERE RECEIVED AND HAVE BEEN ADDED TO THIS REPORT. 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, THE PATIENT DEVELOPED NEW LEFT BUNDLE BRANCH BLOCK AND AN ELECTROCARDIOGRAM REVEALED ATRIO-VENTRICULAR DISSOCIATION. A PERMANENT PACEMAKER WAS IMPLANTED THE FOLLOWING DAY WITH NO SUBSEQUENT ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456599 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention