BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2802313 · Received October 24, 2012

    Report

    Report Number
    2015691-2012-18533
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL REPORT, MEDICAL RECORDS PERTAINING TO THE EVENT WERE OBTAINED. PER THE CONSULTATION REPORT, THE PATIENT HAD SEVERE LEFT VENTRICLE HYPERTROPHY, A PREEXISTING PROSTHETIC HEART VALVE IN THE MITRAL POSITION, AND SHE DID NOT HAVE ANY SIGNS OF A CALCIFIED AORTA. PER THE CARDIOLOGY PROCEDURE REPORT, THE NATIVE ANNULAR DIAMETER WAS 21MM BY TEE. BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 5X20 ZMED BALLOON UNDER RAPID VENTRICULAR PACING (RVP). DURING BAV WITH THE NON-EDWARDS BALLOON, THE PATIENT EXPERIENCED AN EPISODE OF VENTRICULAR TACHYCARDIA WHICH REQUIRED CARDIOVERSION. THE SAPIEN VALVE WAS DESCRIBED AS BEING SUCCESSFULLY POSITIONED AND DEPLOYED; HOWEVER, IT WAS NOTED THAT UPON DEPLOYMENT THE VALVE MOVED VENTRICULAR, WITH TEE SHOWING SUBSEQUENT SIGNIFICANT AORTIC REGURGITATION. A SECOND SAPIEN VALVE WAS THEN POSITIONED AND DEPLOYED ONE STENT LENGTH MORE AORTIC INSIDE THE INITIAL SAPIEN VALVE, WITH TEE SHOWING ONLY MILD CENTRAL AORTIC INSUFFICIENCY (CAI). THE PHYSICIAN WAS SATISFIED WITH THIS RESULT. FOLLOWING REMOVAL OF THE SHEATHS, THE PATIENT DEVELOPED COMPLETE HEART BLOCK AND REQUIRED THE USE OF A TEMPORARY PACEMAKER WITH PLANS TO IMPLANT A PERMANENT PACEMAKER. AN ECHO REPORT COULD NOT BE OBTAINED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION AND DEVICE MALPOSITION REQUIRING INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VENTRICULAR MALPOSITION AND/OR EMBOLIZATION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, A NARROW, CALCIFIED SINOTUBULAR JUNCTION, MINIMAL VALVE CALCIFICATION, AND LOSS OF PACING CAPTURE. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. ADDITIONALLY, THE IFU STATES THAT 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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE 23MM SAPIEN VALVE WAS IMPLANTED TOO VENTRICULAR, RESULTING IN MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). A SECOND 23MM SAPIEN VALVE WAS IMPLANTED MORE AORTIC, WHICH RESOLVED THE CAI. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX23 2951485

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention