BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2902336 · Received January 8, 2013

    Report

    Report Number
    2015691-2013-19047
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. PER THE IFU, DEVICE MIGRATION OR MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR PROCEDURE. IN ADDITION, 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 CS, IT IS POSSIBLE THAT THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO THE FORWARD PRESSURE THAT THE PHYSICIAN PLACED ON THE RF3 DELIVERY DEVICE DURING VALVE DEPLOYMENT. A PHYSICIAN PROCTOR WAS PRESENT AT THE PROCEDURE AND NO CLEAR ROOT CAUSE FOR THE EVENT WAS DETERMINED. 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, UPON DEPLOYMENT, THE SAPIEN VALVE MIGRATED FROM A 60:40 POSITION TO A 70:30 AORTIC POSITION. POST DEPLOYMENT ECHOCARDIOGRAM (TEE) REVEALED A SIGNIFICANT AMOUNT OF PARAVALVULAR LEAK (PVL). THE DECISION WAS MADE TO PERFORM A VALVE IN VALVE PROCEDURE AND DEPLOY A SECOND VALVE MORE VENTRICULAR BY 25% IN AN ATTEMPT TO RESOLVE THE LEAK. A SECOND 26MM SAPIEN VALVE WAS IMPLANTED SUCCESSFULLY WITH A FINAL RESULT OF MINIMAL PVL. THE PATIENT WAS NOTED TO HAVE LEFT THE OPERATING ROOM IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED FROM 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. THERE WAS NO NOTED SEPTAL HYPERTROPHY OR MITRAL ANNULAR CALCIFICATION (MAC). ADDITIONALLY, NATIVE AORTIC LEAFLET / ANNULAR CALCIFICATION WAS REPORTED AS MODERATE WITH NO AORTIC ROOT CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8991 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 59203814

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention