BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3071506 · Received April 22, 2013

    Report

    Report Number
    2015691-2013-19879
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) FOR THE SAPIEN VALVE, CONDUCTION ABNORMALITIES ARE KNOWN COMPLICATIONS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). DAMAGE TO THE MYOCARDIUM AND ITS CONDUCTION SYSTEM 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, IN ADDITION TO THE PROCEDURE ITSELF, IT IS POSSIBLE THE PATIENT'S UNDERLYING CARDIAC PATHOLOGY (E.G. CAD, CHF, VALVULAR HEART DISEASE) CAUSED OR CONTRIBUTED TO THIS 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. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE 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 A TRANSFEMORAL TAVR CASE AFTER THE 26MM SAPIEN VALVE WAS DEPLOYED THE PATIENT WAS IN PERSISTENT COMPLETE HEART BLOCK. HE WAS PACED WITH A TEMPORARY PACER AT 80BPM WITH AN UNDERLYING RATE OF 20BPM AND REMAINED STABLE. THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171113 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3499081

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention