BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3911114 · Received July 2, 2014

    Report

    Report Number
    2015691-2014-01514
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 4, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BIOPROSTHETIC AORTIC VALVE INSUFFICIENCY. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT THIS VALVE WAS REPLACED DUE TO AORTIC INSUFFICIENCY. THE TYPE AND CAUSE OF REGURGITATION, OR INSUFFICIENCY, VARIES DEPENDING UPON MULTIPLE FACTORS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. WITHOUT RETURN OF THE EXPLANTED VALVE, THE SPECIFIC NATURE OF THIS EVENT CANNOT BE CONFIRMED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A QUALITY DEFICIENCY RELATED TO THE EXPLANTED VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. OF NOTE, THE PATIENT ALSO HAD A BIOPROSTHETIC MITRAL VALVE REMOVED DURING THE SAME SURGERY. PLEASE REFERENCE MDR SUBMITTED FOR DEVICE SERIAL #(B)(4).

    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 REPORTED THAT A (B)(6) MALE HAD THIS AORTIC VALVE EXPLANTED, AFTER AN IMPLANT DURATION OF APPROXIMATELY NINE (9) YEARS AND TWO (2) MONTHS, DUE TO BIOPROSTHETIC AORTIC INSUFFICIENCY. THE OPERATIVE REPORT DOES NOT DOCUMENT ANY SPECIFIC FINDINGS ON THE DEVICE DURING EXPLANTATION. ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385787 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R