BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3920103 · Received July 8, 2014

    Report

    Report Number
    2025587-2014-00451
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    October 16, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: 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). CONDUCTION DISTURBANCES DO NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6).

    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 THE PATIENT WAS NOTED TO HAVE SINO ATRIAL (SA) NODE DYSFUNCTION AND ATRIO-VENTRICULAR (AV) BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED LATER THE SAME DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396224 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention