BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 4682198 · Received April 10, 2015

    Report

    Report Number
    2015691-2015-00824
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    February 17, 2015
    Report Date
    March 18, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE = (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. LEAFLET TEARS AND LEAFLET DISRUPTIONS OCCURRING OVER TIME ARE A FORM OF STRUCTURAL VALVE DETERIORATION (SVD) THAT MAY ULTIMATELY RESULT IN SIGNIFICANT REGURGITATION REQUIRING REPLACEMENT OF THE VALVE. WITHOUT RETURN OF THE DEVICE, THE REPORT OF TEARS COULD NOT BE CONFIRMED AND CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 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, EDWARDS RECEIVED INFORMATION THAT A 25MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWELVE (12) YEARS, ONE (1) MONTH DUE TO SEVERE AORTIC VALVE INSUFFICIENCY SECONDARY TO MULTIPLE LEAFLET TEARS. IT WAS REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE OPERATIVE REPORT INDICATED "INSPECTION OF THE AORTIC VALVE REVEALED THAT THERE IS A TEAR IN ABOUT 3 PLACES ALONG CLOSE TO THE COMMISSURAL AREA OF THE LEAFLETS, MAYBE EVEN 4 PLACES. THERE WAS SURPRISINGLY ABSENCE OF CALCIFICATION. THE VALVE WAS THEN REMOVED FROM THE AORTIC ANNULUS AND A PIECE OF THE VALVE TISSUE WAS SENT OFF TO THE LABORATORIES FOR GRAM STAIN, WHICH NOT REVEAL ANY ORGANISM OR WBC." THERE WERE NO COMPLICATIONS REPORTED. DURING THE PROCEDURE THE PATIENT ALSO WENT UNDER MITRAL VALVE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238491 CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention