BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSFEMORAL BALLOON CATHETER

    MDR report key: 3017023 · Received March 22, 2013

    Report

    Report Number
    2015691-2013-19626
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THE TAVR PROCEDURE. 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 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, ARRHYTHMIAS, RBBB, AND LFB MAY HAVE CONTRIBUTED TO THE EVENT OR PUT THE PATIENT AT HIGHER RISK FOR THE DEVELOPMENT OF HEART BLOCK DURING THIS PROCEDURE. 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. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A (B)(4), AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4). NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSFEMORAL TAVR PROCEDURE, THE PATIENT HAD AN EPISODE OF COMPLETE HEART BLOCK AFTER BALLOON AORTIC VALVULOPLASTY (BAV). ADDITIONAL INFORMATION REVEALS THE PATIENT HAD BASELINE ATRIAL FIBRILLATION AT A RATE OF 55 WITH RIGHT BUNDLE BRANCH BLOCK (RBBB), LEFT FASICULAR BLOCK, AND KNOWN POOR SYSTOLIC FUNCTION. FOLLOWING THE EPISODE OF COMPLETE HEART BLOCK, THE BACK-UP PACEMAKER WAS SET AT 60 BPM. FOLLOWING SAPEIN DEPLOYMENT THE PATIENT WAS PACER DEPENDENT AND THE RATE WAS SET AT 60 BPM. FOLLOWING THE PROCEDURE, A SINGLE CHAMBER PACER WAS IMPLANTED. THE PATIENT'S VITALS REMAINED STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT WAS DISCHARGED TO THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119850 EDWARDS TRANSFEMORAL BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350BC20 59337958

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention