BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3021410 · Received March 26, 2013

    Report

    Report Number
    2015691-2013-19656
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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, CONDUCTION SYSTEM INJURIES (DEFECTS) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY, THE USE OF ANESTHESIA, AND THE OVERALL TAVR PROCEDURE. 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 HEART BLOCK CANNOT BE CONFIRMED. HOWEVER, IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT'S UNDERLYING HEART DISEASE (A-FIB, CHF, CAD, HISTORY OF SYNCOPAL EPISODES) MAY HAVE CONTRIBUTED TO THE EVENT. THE IFU 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 PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, AFTER SUCCESSFUL DEPLOYMENT OF A 23 MM SAPIEN VALVE, THE PATIENT'S BLOOD PRESSURE DROPPED TO 32/20. THE PATIENT WAS NOTED TO HAVE RV STUNNING REQUIRING BRIEF CPR AND ADMINISTRATION OF EPINEPHRINE (50 MCG) BOLUS WITH EXCELLENT RESPONSE AND RECOVERING OF RV FUNCTION. THE PATIENT WAS ALSO NOTED TO HAVE COMPLETE HEART BLOCK AFTER A LONG RUN OF PACING THAT RESPONDED TO TEMPORARY PACING. A SECOND TEMPORARY PACEMAKER WAS PLACED VIA THE RIGHT SUBCLAVIAN WITH EXCELLENT CAPTURE THRESHOLD. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AT THE END OF THE PROCEDURE WITH A BLOOD PRESSURE OF 127/79. A POST PROCEDURE TEE REVEALED NORMAL LV FUNCTION AND NORMAL RV FUNCTION. THE PATIENT WAS TRANSFERRED TO THE SICU FOR CLOSE OBSERVATION. IT WAS REPORTED THAT APPROXIMATELY 24 HOURS POST IMPLANT THE PATIENT CONTINUED TO HAVE COMPLETE HEART BLOCK AND A PERMANENT PACE MAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123768 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention