BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3053501 · Received April 11, 2013

    Report

    Report Number
    2015691-2013-19796
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL OPERATIVE REPORT INDICATED THAT AFTER THE SECOND VALVE WAS DEPLOYED, TEE REVEALED NO AORTIC REGURGITATION AND 1+ PERIVALVULAR REGURGITATION (PVL). 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 RECORD (DHR) REVIEW FOR THE VALVE WAS NOT PERFORMED/REQUIRED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. IT SHOULD BE NOTED THAT ALL VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO RELEASE. PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION AND VALVE REGURGITATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER HEART VALVE REPLACEMENT PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, 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 AND ANATOMICAL 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. THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, IS INDICATED FOR TRANSFEMORAL OR TRANSAPICAL DELIVERY. THE SAFETY AND EFFECTIVENESS OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE VIA TRANSAORTIC DELIVERY HAS NOT BEEN ESTABLISHED. IN THIS CASE, THE CAUSE OF THE PVL WAS NOT REPORTED BY THE OPERATORS, OR EVIDENT IN THE OPERATIVE REPORT; HOWEVER, IT IS POSSIBLE THAT THE PARAVALVULAR LEAK OCCURRED 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. 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.

    Additional Manufacturer Narrative · 1

    THE DATE REPORTED UNDER MFG REPORT # 2015691-2013-19796 - FOLLOWUP NO 1 SHOULD HAVE BEEN (B)(4) 2013 AND NOT (B)(4) 2013 AS INDICATED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING THE TRANSAORTIC TAVR PROCEDURE, AFTER THE VALVE WAS DEPLOYED THE ECHOCARDIOGRAM SHOWED MODERATE TO SEVERE PVL. THE DECISION WAS MADE TO DEPLOY A SECOND SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156106 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention