BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2213273 · Received August 16, 2011

    Report

    Report Number
    2015691-2011-16053
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. AS THE SUBJECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION BY EDWARDS, NO ADDITIONAL INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED STENOTIC LEAFLETS (RIGID) CAN BE PERFORMED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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 AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 115 MONTHS, AND REPLACED WITH ANOTHER EDWARDS' PERICARDIAL VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO STENOSIS AND REGURGITATION. OPERATIVE REPORT INDICATES, "THERE WAS DENSE ADHESIONS OVER THE RIGHT ATRIUM AND OVER THE ENTIRE VENTRICLE. THE ASCENDING AORTA IS MODERATELY DILATED TO 4.2 CM. THERE IS SEVERE BIOPROSTHETIC VALVE DISEASE WITH SEVERE RIGIDITY OF ALL THREE LEAFLETS, AND RETRACTION OF THE LEAFLETS SO THEY DID NOT HAVE ADEQUATE COAPTATION RESULTING IN AORTIC INSUFFICIENCY".

    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 1D0588

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R