BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART

    MDR report key: 2905621 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19072
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) FOR THE SAPIEN VALVE, CONDUCTION ABNORMALITIES ARE A KNOWN COMPLICATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DAMAGE TO THE MYOCARDIUM AND ITS CONDUCTION SYSTEM CAUSES ACQUIRED HEART BLOCK AND CAN RESULT IN HEART BLOCK DURING OR AFTER THE PROCEDURE. THIS TYPICALLY OCCURS IN PATIENTS WITH UNDERLYING CARDIAC DISEASE AND/OR CONDUCTION ABNORMALITIES. 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 HEART BLOCK INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES, AND CERTAIN MEDICATIONS (I.E. BETA-BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN THIS CASE, THE ROOT CAUSE FOR THE EVENT CANNOT BE CONFIRMED. IT IS POSSIBLE THAT PROCEDURAL FACTORS AND THE PATIENT¿S UNDERLYING CARDIAC PATHOLOGY (CONGESTIVE HEART FAILURE, VALVULAR HEART DISEASE WITH SEVERE AORTIC VALVE / LEAFLET CALCIFICATION) CONTRIBUTED TO THE EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AFTER THE VALVE WAS DEPLOYED THE PATIENT DEVELOPED A WIDENED PR INTERVAL AND A LOWER HEART RATE. THE PATIENT WAS MONITORED IN THE OR FOR AN HOUR POST IMPLANT AND THE TEMPORARY PACEMAKER WAS TURNED OFF REVEALING COMPLETE HEART BLOCK WITH NO IDIOVENTRICULAR RHYTHM. A PERMANENT PACEMAKER WAS IMPLANTED BEFORE THE PATIENT LEFT THE PROCEDURE ROOM. THE PATIENT WAS STABLE AFTER THE TAVR PROCEDURE AND WAS SUCCESSFULLY DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11020 EDWARDS SAPIEN TRANSCATHETER HEART AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention