BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS® PERIMOUN MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2873368 · Received December 14, 2012

    Report

    Report Number
    2015691-2012-18857
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DHR IS CURRENTLY IN PROCESS. DEVICE NOT RETURNED, HAS NOT BEEN EXPLANTED. NO REPORTS HAVE BEEN PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT IS PRESENTING WITH HIGH GRADIENT AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS. CUSTOMER REPORTED STRUCTURAL VALVE DETERIORATION AFTER 5 YEARS. DETERIORATION OF HAEMODYNAMIC FUNCTION. INCREASE OF MEAN PRESSURE GRADIENT FROM 9.5 MMHG IN (B)(6) 2007, TO 25 MMHG IN (B)(6) 2012; RIGHT CORONARY CUSP IS THICKENED AND IMMOBILE - STRUCTURAL VALVE DETERIORATION. AT THE MOMENT PATIENT IS WITHOUT SYMPTOMS, THEREFORE, WATCHFUL WAITING. AFTER FIVE YEARS IT CAN BE SEEN (WITH TTE) THE RIGHT CORONARY CUSP NOT PROPERLY MOVING (DUE TO THICKENING). PROBABLY THIS IS BEGINNING DETERIORATION OF THE MAGNA EASE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUN MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R