BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2874620 · Received December 15, 2012

    Report

    Report Number
    2015691-2012-18861
    Event Type
    Injury
    Date Received
    December 15, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE REMAINS IMPLANTED IN THE PATIENT. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE SAPIEN VALVE WAS NOT PERFORMED/REQUIRED AS PER THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, AORTIC INSUFFICIENCY IS KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. 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, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT APPEARS THAT THE ROOT CAUSE OF THE REPORTED EVENT IS POSSIBLY RELATED TO A COMBINATION OF PROCEDURAL (FIRST VALVE WAS DEPLOYED TO VENTRICULAR WITH NATIVE LEAFLET OVERHANG) AND PATIENT FACTORS ( LONG AORTIC VALVE LEAFLETS). 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. 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 CLINICAL SPECIALIST (CS), DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, DURING DEPLOYMENT, THE SAPIEN VALVE WAS MANIPULATED TOWARDS THE VENTRICLE RESTING IN A 40:60 VENTRICULAR POSITION. THE TEE SHOWED MODERATE AI, AN EF OF 50%, AND A NATIVE LEAFLET WAS SEEN TO BE OVERHANGING THE VALVE FRAME. THE DECISION WAS MADE TO PERFORM A VALVE IN VALVE PROCEDURE AND DEPLOY AS SECOND VALVE MORE AORTIC IN AN ATTEMPT TO RESOLVE THE LEAK. A SECOND 23MM SAPIEN VALVE WAS IMPLANTED SUCCESSFULLY WITH A FINAL RESULT OF MILD PV LEAK. THE PATIENT WAS NOTED TO HAVE LEFT THE OPERATING ROOM IN STABLE CONDITION. ADDITIONAL INFORMATION PROVIDED BY THE CS, INDICATED THAT THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM/VALVE WAS GOOD, BALLOON INFLATION WAS HELD > THAN 3 SECONDS, AND THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT.

    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 9000TFX23 59300067

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention