BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120551 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20125
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 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 WAS NOT EXPLANTED FROM THE PATIENT; HOWEVER, PER REPORT, THERE WAS NO DEVICE MALFUNCTION. A DEVICE HISTORY REVIEW (DHR) FOR THE VALVE WAS NOT PERFORMED OR REQUIRED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. FURTHERMORE, ALL VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO TERMINATION. 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. 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. IN THIS CASE, PER REPORT, IT APPEARS THAT THE ROOT CAUSE OF THE REPORTED EVENT IS DUE TO THE SEVERELY ELLIPTICAL SHAPE OF THE PATIENT¿S NATIVE ANNULUS WHICH CAUSED A SHIFT DURING IMPLANTATION. ADDITIONALLY, THE PATIENT¿S SEVERELY CALCIFIED NATIVE VALVE COULD HAVE CONTRIBUTED TO THE EVENT. 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSFEMORAL TAVR PROCEDURE, THE FIRST 26MM SAPIEN VALVE WAS PREPPED AND POSITIONED IN A 50:50 POSITION, HOWEVER, DURING DEPLOYMENT THE VALVE SHIFTED AORTIC RESTING 80:20 WITHIN THE NATIVE ANNULUS. PER REPORT, THE PATIENT¿S AORTIC VALVE HAD A VERY ELLIPTICAL SHAPE WHICH CAUSED A SHIFT DURING IMPLANTATION. POST DEPLOYMENT ECHOCARDIOGRAM SHOWED MODERATE CENTRAL REGURGITATION WITHOUT ANY HEMODYNAMIC COMPROMISE. IN ORDER TO TROUBLESHOOT, THE DECISION WAS MADE TO IMPLANT A SECOND VALVE. THE SECOND 26MM SAPIEN VALVE WAS IMPLANTED WITH NO CENTRAL AI NOTED AFTER THE VALVE DEPLOYMENT. THE PATIENT WAS NOTED TO HAVE BEEN TRANSFERRED TO THE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221355 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 59355122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention