BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2993436 · Received March 7, 2013

    Report

    Report Number
    2015691-2013-19483
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED/REQUIRED AS THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. PER THE IFU, ARRHYTHMIAS ARE A KNOWN ADVERSE EVENT ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. THERE ARE MULTIPLE POTENTIAL CAUSES FOR BRADYARRHYTHMIAS IN A CARDIAC PATIENT INCLUDING, BUT NOT LIMITED TO, CARDIAC DAMAGE RELATED TO AGING, HEART DISEASE OR MI, HTN, OR A COMPLICATION OF SURGERY. IN THIS CASE, IN ADDITION TO THE PROCEDURE, THE PATIENT HAS MULTIPLE CO-MORBIDITIES (CALCIFIED AORTIC STENOSIS, CHF, HTN) THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. 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 CLINICAL SPECIALIST, ONE DAY POST TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PATIENT WAS NOTED TO BE IN SINUS BRADYCARDIA (HEART RATE WAS IN THE 40'S) REQUIRING THE IMPLANT OF A PERMANENT PACEMAKER (PPM). THE PATIENT WAS NOTED TO BE IN STABLE CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97847 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59106600

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention