BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3173341 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20367
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF IMPLANT: (B)(6) 2012. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. IN ADDITION, A DESIGN HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED OR PERFORMED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SOB AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. PER THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE STENOSIS CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), TRAUMA (CARDIO-PULMONARY RESUSCITATION, BLUNT CHEST TRAUMA), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. IN THIS CASE, THE ROOT CAUSE FOR THE REPORTED VALVE STENOSIS IS UNKNOWN, AS NONE OF THE PREVIOUSLY MENTIONED FACTORS WERE REPORTED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS CASE WILL BE REOPENED AND INVESTIGATED. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS SALE REPRESENTATIVE, ONE YEAR POST TAVR THE PATIENT ECHO SHOWED THE PATIENT HAD A MEAN GRADIENT OF 50MMHG. THE PHYSICIAN IS CONSIDERING PERFORMING EITHER A BALLOON VALVULOPLASTY (BAV) OR IMPLANTING A SECOND VALVE. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE PERFORMED, BUT TO DATE NONE HAVE BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274289 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59186293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention