BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2131045 · Received June 16, 2011

    Report

    Report Number
    2015691-2011-15725
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE ATTEMPTS, THE HEALTHCARE PROVIDER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EXPLANT DUE TO PATIENT PRIVACY REGULATIONS. IT WAS LEARNED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, NO ADDITIONAL INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IT WAS INITIALLY REPORTED THAT THE DEVICE WAS REMOVED DUE TO UNKNOWN REASONS. (CORRECTION) THE DEVICE WAS EXPLANTED DUE AORTIC STENOSIS AND CALCIFICATION. NO OTHER DETAILS WERE PROVIDED. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    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 EDWARDS' HEART VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 105 MONTHS, AND REPLACED WITH SAME MODEL EDWARDS' VALVE. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, THE REASON FOR EXPLANT AND ADDITIONAL REQUESTED INFORMATION WERE NOT PROVIDED DUE TO PATIENT PRIVACY REGULATIONS.

    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 1L1694

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention