BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3840565 · Received May 30, 2014

    Report

    Report Number
    2025587-2014-00334
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THESE COMPLICATIONS OF 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, HOWEVER, MAY BE RELATED TO THE PATIENT'S PRE-EXISTING BRADYCARDIA. (B)(4). LOCATION : HOSPITAL.

    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 ELECTROCARDIOGRAM (ECG) SHOWED COMPLETE HEART BLOCK WITH HEART RATE AT 40-50, INITIALLY TREATED WITH TEMPORARY PACING. FOUR DAYS POST IMPLANT, A PERMANENT PACEMAKER WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS. IT WAS REPORTED THAT PRIOR TO THE VALVE IMPLANT PROCEDURE, THE PATIENT HAD BRADYCARDIA ¿ ATRIAL FIB/FLUTTER WITH A VENTRICULAR RATE IN THE 50'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319526 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention