BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2884686 · Received December 24, 2012

    Report

    Report Number
    2015691-2012-18950
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS AND CLARIFICATION FOR THE EVENT WAS RECEIVED FROM THE EDWARDS CLINICAL SPECIALIST. PER THE INFORMATION RECEIVED, THE PATIENT WAS IMPLANTED WITH TWO 26MM SAPIEN TRANSCATHETER HEART VALVES. THE SINOTUBULAR JUNCTION (STJ) WAS 35.3MM IN DIAMETER WITH MILD CALCIFICATION. THERE WAS NO VENTRICULAR SEPTAL HYPERTROPHY. THE AORTIC VALVE / LEAFLET CALCIFICATION WAS ASSESSED AS MODERATE. THE AORTIC ROOT- DEGREE / DISTRIBUTION OF LEAFLET CALCIFICATION WAS ALSO MODERATE. THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE VALVE AND THE DELIVERY SYSTEM WERE ASSESSED AS ADEQUATE/GOOD. THE PRE-DEPLOYMENT POSITION OF THE FIRST VALVE WAS 60:40 (AORTIC). THE VALVE FINAL POSITION POST DEPLOYMENT WAS 70:30 (AORTIC). THE BALLOON INFLATION WAS HELD DURING DEPLOYMENT FOR MORE THAN THREE SECONDS. VENTILATION WAS ALSO HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT. THE PARAVALVULAR LEAK (PVL)WAS ATTRIBUTED TO HIGH POSITIONING OF THE FIRST VALVE. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, VALVE MALPOSITION AND AORTIC INSUFFICIENCY ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. MANY CASES OR PARAVALVULAR LEAK ARE MILD TO MODERATE (<3+), AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. PHYSICIANS ARE EXTENSIVELY TRAINED 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. IN THIS CASE, THE VALVE WAS POSITIONED 60:40 AND DEPLOYED IN A 70:30 AORTIC POSITION LEADING TO PVL . IT IS POSSIBLE THAT A COMBINATION OF PATIENT FACTORS (MODERATELY CALCIFIED AORTIC VALVE/AORTIC ROOT AND LEAFLETS) AND PROCEDURAL FACTORS CONTRIBUTED TO THE MOVEMENT OF THE VALVE DURING DEPLOYMENT. IT WAS NOTED THAT THE AORTIC INSUFFICIENCY WAS A RESULT OF THE AORTIC DEPLOYMENT OF THE VALVE AND NOT DUE TO VALVE DYSFUNCTION. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AFTER THE FIRST 23MM SAPIEN TRANSCATHETER HEART VALVE WAS DEPLOYED IN A TOO VENTRICULAR POSITION AND THERE WAS A MODERATE PARAVALVULAR LEAK REQUIRING IMPLANTATION OF A SECOND VALVE. THERE WERE NO MAJOR INCIDENTS DURING THE PROCEDURE AND THE PATIENT LEFT THE ROOM IN STABLE CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention