BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3854207 · Received June 6, 2014

    Report

    Report Number
    2025587-2014-00359
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 2, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION:PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION DISTURBANCES ARE A POTENTIAL PROCEDURAL COMPLICATION AND ARE 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. ACCORDING TO LITERATURE REVIEW AND THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR CONDUCTION DISTURBANCES DURING OR AFTER THE PROCEDURE. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ONSET OF CONDUCTION DEFECTS INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES AND CERTAIN MEDICATIONS (I.E. BETA BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN THIS CASE, THE EXACT CAUSE OF THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED 8 DAYS POST VALVE IMPLANT WITH NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INITIALLY THE PATIENT HAD EXHIBITED EPISODES OF BRADYCARDIA, WHICH PROGRESSED TO ATRIO-VENTRICULAR (AV) HEART BLOCK AS THE PATIENT WAS BEING MONITORED. IT ALSO WAS REPORTED THAT THE EPISODES POSSIBLY WERE RELATED TO THE PATIENT'S HISTORY OF SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332932 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention