BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 5100640 · Received September 24, 2015

    Report

    Report Number
    2015691-2015-02519
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AORTIC STENOSIS. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE OF THE EVENT IS INDETERMINABLE; HOWEVER, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A (B)(6) PATIENT WAS PRESENTED FOR CLINICAL TRIAL TRANSCATHETER VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY NINE (9) YEARS DUE TO SEVERE AORTIC STENOSIS WITH CALCIFICATION ON ASCENDING AORTA. THE ORIGINAL IMPLANTED VALVE WAS REPORTED TO BE A 21MM AORTIC PERICARDIAL VALVE. IT WAS REPORTED THAT THE 21MM PERICARDIAL VALVE WAS FAILING AND THAT THE SITE DECIDE TO TREAT OUTSIDE THE TRIAL. A 23MM NON-EDWARDS TRANSCATHETER VALVE WAS IMPLANTED VIA VALVE-IN-VALVE PROCEDURE TO TREAT THE SEVERE AORTIC STENOSIS. THE PATIENT WAS TAKEN TO THE CARDIAC CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631167 CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R