BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2955655 · Received February 11, 2013

    Report

    Report Number
    2015691-2013-19248
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 26, 2013
    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

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. 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, PER THE MEDICAL RECORDS, THE RESTRICTION OF LEAFLET MOBILITY WAS DUE TO PARTIAL COMMISSURAL FUSION WHICH RESTRICTED LEAFLET MOBILITY. THE INCREASED AORTIC GRADIENT WAS REDUCED BY THE BAV PROCEDURE. 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. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE 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.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE PARTNERS 1 CLINICAL TRIAL, FIVE YEARS POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE PATIENT BECAME SYMPTOMATIC WITH DIZZINESS AND LIGHTHEADEDNESS. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH PROSTHETIC AORTIC VALVE STENOSIS WITH DECREASED VALVE OPENING AND RAISED GRADIENTS. THE PATIENT UNDERWENT PROSTHETIC BALLOON AORTIC VALVULOPLASTY (BAV). PER THE MEDICAL RECORDS, THE SAPIEN LEAFLETS WERE THIN, WITHOUT THICKENING OR CALCIFICATION. THERE WAS MODERATE-SEVERE PROSTHESIS STENOSIS, DUE TO PARTIAL COMMISSURAL FUSION. THE RESTRICTION OF THE SAPIEN VALVE LEAFLETS WAS MOSTLY AT THE TIPS. THERE WAS NO AORTIC VALVE REGURGITATION. PER THE OPERATIVE REPORT, TEE DEMONSTRATED COMMISSURAL FUSION OF A SINGLE COMMISURE. CONSEQUENTLY, THE TWO LEAFLETS ATTACHED TO THAT COMMISURE HAD ABNORMAL LEAFLET MOTION; HOWEVER, THE OTHER TWO COMMISURES APPEARED NORMAL AND THE LAST COMMISURE ALSO HAD NORMAL MOTION. FOLLOWING BAV, THE PATIENT WAS NOTED TO HAVE A SIGNIFICANT IMPROVEMENT IN HEMODYNAMICS AND A DECREASE IN GRADIENTS. POST OPERATIVE TEE DEMONSTRATED IMPROVEMENT IN VALVULAR FUNCTION WITHOUT AORTIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58454 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention