BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3533739 · Received December 23, 2013

    Report

    Report Number
    2015691-2013-21923
    Event Type
    Injury
    Date Received
    December 23, 2013
    Date of Event
    April 13, 2012
    Report Date
    November 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT 2 OF 2 FOR THIS ARTICLE. REPORT 1 0F 2 IS FILED UNDER 2015691-2013-21900. THIS REPORT CAPTURES THE TWO (2) CE PERIMOUNT BIOPROSTHETIC VALVES REQUIRING REINTERVENTION. THE SURGICAL BIOPROSTHETIC VALVES REMAIN IMPLANTED THEREFORE OUR INVESTIGATION OF THE TWO VALVES REQUIRING REINTERVENTION IS LIMITED. BASED ON THE INFORMATION PRESENTED IN THE ARTICLE THE REASON FOR REINTERVENTION WAS STENOSIS AND/OR REGURGITATION. STENOSIS OF AN IMPLANTED VALVE, LIKE REGURGITATION, MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION. THERE ARE CASES OF SVD THAT RESULT IN A COMBINATION OF REGURGITATION AND STENOSIS. THE MEAN AGE IN YEARS FOR ALL PATIENTS DISCUSSED IN THIS ARTICLE WAS 21.7; THEREFORE, PATIENT AGE MAY HAVE BEEN A CONTRIBUTING FACTOR IN THESE TWO EVENTS.

    Description of Event or Problem · 1

    ARTICLE: 10.1007/S00392-012-0503-8 " PERCUTANEOUS IMPLANTATION OF THE EDWARDS SAPIEN PULMONIC VALVE: INITIAL RESULTS IN THE FIRST 22 PATIENTS"; PUBLISHED 30-AUG-2012, CLIN RES CARDIOL (2013) 102:119¿128 ABSTRACT: BACKGROUND: PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) WAS INTRODUCED IN 2000 AS AN INTERVENTIONAL PROCEDURE FOR THE TREATMENT OF RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) DYSFUNCTION. THE NEW EDWARDS SAPIEN PULMONIC VALVE HAS REACHED CE CERTIFICATION AT THE END OF 2010 THUS OFFERING AN ATTRACTIVE ALTERNATIVE WITH EXTENDED SIZES (23 AND 26 MM) TO THE CONVENTIONAL MELODY_ VALVE (SIZES 18, 20 AND 22 MM). PATIENTS: OVER A 1-YEAR PERIOD, PPVI USING THE EDWARDS SAPIEN PULMONIC VALVE WAS PERFORMED IN 22 PATIENTS USING A STANDARDIZED PROCEDURE. PRIMARY DIAGNOSIS WAS TETRALOGY OF FALLOT (N = 11), PULMONARY ATRESIA (N = 2), TRUNCUS ARTERIOSUS (N = 3), TGA/PS-RASTELLI (N = 1), ROSS SURGERY (N = 2), DOUBLE OUTLET RIGHT VENTRICLE (N = 2) AND ABSENT PULMONARY VALVE SYNDROME (N = 1). THE CHARACTER OF THE RVOT FOR PPVI WAS TRANSANNULAR PATCH (N = 4), BIOPROSTHESIS (CARPENTIER-EDWARDS ) (N = 2), HOMOGRAFT (N = 5) AND CONTEGRA CONDUIT (N = 11). THE LEADING HEMODYNAMIC PROBLEM. THE EDWARDS PERIMOUNT PROSTHESIS WERE REPLACED DUE TO STENOSIS AND/OR REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671616 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES HVTUNKNOWN PERICARDIAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R