BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2072812 · Received April 29, 2011

    Report

    Report Number
    2015691-2011-15360
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE PROBLEM: (B)(4) - PROSTHETIC VALVE STENOSIS. DEVICE DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WILL BE REPORTED ONCE COMPLETED. THERE ARE MANY FACTORS THAT MAY CAUSE VALVE STENOSIS (E.G CALCIFICATION, PANNUS GROWTH...ETC); WITHOUT DEVICE RETURN AND EVALUATION, THE ROOT CAUSE CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 156 MONTHS, DUE TO PROSTHETIC VALVE STENOSIS. OPERATIVE REPORT INDICATES, " THE ECHOCARDIOGRAM CONFIRMED A LIMITED MOBILITY OF AT LEAST ONE OF THE THREE LEAFLETS OF THE PROSTHETIC VALVE, AND A VALVE GRADIENT OF 40 TO 45 MMHG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 7K1118

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention