BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 23MM AORTIC VALVE

    MDR report key: 4132376 · Received October 1, 2014

    Report

    Report Number
    2025587-2014-00717
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 18, 2014
    Report Date
    December 31, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES, SUCH AS LEFT BUNDLE BRANCH BLOCK AND RIGHT BUNDLE BRANCH BLOCK, 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT UPON DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC HEART VALVE THE PATIENT EXHIBITED LEFT BUNDLE BRANCH BLOCK. THERE WAS NO TREATMENT AND CONDITION REMAINED ONGOING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SIX DAYS POST-IMPLANT, THE PATIENT WAS OBSERVED TO HAVE ALTERNATING RIGHT AND LEFT BUNDLE BRANCH BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED THE FOLLOWING DAY TO RESOLVE THE CONDUCTION DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612257 COREVALVE 23MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-2334

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention