BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2882660 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18911
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE OPERATIVE REPORT INDICATED THAT THE POST DEPLOYMENT ECHOCARDIOGRAM OF THE FIRST VALVE SHOWED MODERATE TO SEVERE PARAVALVULAR REGURGITATION WITH FLOW REVERSAL IN THE DESCENDING THORACIC AORTA. IN ORDER TO TROUBLESHOOT, THE DECISION WAS MADE TO IMPLANT A SECOND VALVE. THE SECOND 26MM SAPIEN VALVE WAS POSITIONED SLIGHTLY LOWER THAN THE PREVIOUS 26MM SAPIEN VALVE AND DEPLOYED UNDER RAPID PACING. POST DEPLOYMENT, THERE WAS TRIVIAL PARAVALVULAR REGURGITATION AND IMPROVED HEMODYNAMICS. THE PATIENT WAS NOTED TO BE STABLE AT THE END OF THE PROCEDURE AND DISCHARGED HOME POST OPERATIVE DAY 2. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED/PERFORMED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. HOWEVER, IT SHOULD BE NOTED THAT 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, PARAVALVULAR LEAK IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. 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. PHYSICIANS ARE EXTENSIVELY TRAINED BE 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. ALTHOUGH THE EXACT ROOT CAUSE FOR THE REPORTED PVL CANNOT BE CONFIRMED, IT APPEARS THAT PROCEDURAL FACTORS (DEPLOYMENT TOO AORTIC) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, IT IS UNKNOWN WHICH SAPIEN VALVE WAS IMPLANTED FIRST; THEREFORE, THE INFORMATION PERTAINING TO BOTH VALVES HAS BEEN PROVIDED BELOW: MODEL 9000TFX26, SERIAL # (B)(4), LOT # 59300058 (MGR. 18-JUN-2012/EXP. 28-MAY-2012). MODEL 9000TFX26, SERIAL # (B)(4), LOT # 59102826 (MGR. 10-AUG-2012/EXP. 16-JUL-2014). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE PATIENT REGISTRY, DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE DECISION WAS MADE TO IMPLANT A SECOND 26MM SAPIEN VALVE.

    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 80 YR Required Intervention