BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3973865 · Received August 1, 2014

    Report

    Report Number
    2025587-2014-00541
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    January 13, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES SUCH AS LEFT BUNDLE BRANCH BLOCK AND COMPLETE HEART BLOCK ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED). THE ELEVATED CREATININE LEVEL, WHICH INDICATES RENAL INJURY OR FAILURE, IS A KNOWN SIDE EFFECT OF CERTAIN BLOOD PRESSURE MEDICATIONS OR REACTION TO FLUOROSCOPIC DYES AND IS A POTENTIAL ADVERSE EFFECT PER THE DEVICE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EXPLANTED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE 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, AN ELECTROCARDIOGRAM (ECG) SHOWED LEFT BUNDLE BRANCH BLOCK (LBBB). SUBSEQUENTLY, THE PATIENT WAS NOTED WITH COMPLETE HEART BLOCK (CHB), WHICH WAS MANAGED WITH TEMPORARY PACING. A PERMANENT PACEMAKER IMPLANT WAS INTENDED BUT NOT ATTEMPTED DUE TO THE PATIENT¿S HEMODYNAMIC INSTABILITY. CONTINUOUS VENO-VENOUS HEMODIALYSIS WAS INITIATED FOR AN ELEVATED CREATININE LEVEL DUE TO FLUID OVERLOAD THAT WAS POSSIBLY PROCEDURE-RELATED. THE PATIENT ALSO REMAINED ON A VENTILATOR POST-IMPLANT DUE TO RESPIRATORY FAILURE THAT WAS POSSIBLY PROCEDURE-RELATED. IT WAS REPORTED THAT THE PATIENT SUBSEQUENTLY PASSED AWAY ELEVEN DAYS POST-IMPLANT DUE TO CARDIOGENIC SHOCK; IT WAS REPORTED THAT THE CARDIOGENIC SHOCK WAS NOT RELATED TO EITHER THE DEVICE OR THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450415 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention