BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 4131816 · Received October 1, 2014

    Report

    Report Number
    2025587-2014-00716
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    August 21, 2014
    Report Date
    February 17, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CONDUCTION DISTURBANCES SUCH AS LEFT BUNDLE BRANCH BLOCK (LBBB) ARE KNOWN POTENTIAL ADVERSE EFFECTS PER COREVALVE INSTRUCTIONS FOR USE (IFU). CONDUCTION DISTURBANCES ARE A KNOWN CAUSE OF BRADYCARDIA, BUT CAN BE AFFECTED BY CERTAIN MEDICATIONS OR OTHER PRE-EXISTING PATIENT CONDITIONS. A CONCLUSIVE CAUSE OF THE BRADYCARDIA COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE REPORT OF PATIENT EXPIRATION AT 4 DAYS POST-IMPLANT WAS DETERMINED TO BE DUE TO THE BRADYCARDIA. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PERCUTANEOUS AORTIC VALVE (PAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    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) WHICH WAS TREATED WITH MEDICINE. THE LBBB WAS LISTED AS A CONTINUING CONDITION UPON THE PATIENT¿S DISCHARGE. FOUR DAYS POST-IMPLANT, THE PATIENT EXPERIENCED BRADYCARDIA AT HOME AND PRESENTED TO AN EMERGENCY ROOM, WHERE AN ECG CONFIRMED BRADYCARDIA. IT WAS REPORTED THE PATIENT PASSED AWAY IN THE EMERGENCY ROOM. THE CAUSE OF DEATH WAS LISTED AS BRADYCARDIA, WITH THE DEATH POSSIBLY RELATED TO THE VALVE. AN AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612726 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death