BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3811348 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01145
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, CUSTOMER REPORT OF CALCIFICATION WAS CONFIRMED. MINIMAL TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. THE FREE MARGIN OF ALL THREE LEAFLETS EXHIBITED MINIMAL TO MODERATE CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT, INTO THE ORIFICE, AT THE OUTFLOW ASPECT, INTO THE ORIFICE, AND AT BOTH THE STENT INFLOW AND STENT OUTFLOW. TWO TEARS WERE OBSERVED ON LEAFLET 1, A TEAR WAS OBSERVED ON LEAFLET 2 AT THE COMMISSURE, AND A PARTIAL TEAR WAS NOTICED ON THE CUSP OF LEAFLET 3 ON THE INFLOW ASPECT. THE TEAR ON LEAFLET 3 DID NOT PENETRATE THROUGH THE ENTIRE THICKNESS OF THE LEAFLET. CALCIFICATION WAS OBSERVED NEAR THE REGIONS OF THE TEARS. HEMATOMA WAS OBSERVED ON TWO OF THE THREE LEAFLETS. THICKENED AND SWOLLEN TISSUE WAS OBSERVED ON ALL THREE LEAFLETS AT ALL THREE COMMISSURES. INCIDENTAL FINDINGS RELATED TO EXPLANT INCLUDE: OBSERVED COMMISSURE DISTORTION, EXPOSED WIREFORM, AND SEWING RING CUTS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE¿S HEMODYNAMIC PERFORMANCE. IN THIS CASE, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    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 THIS PATIENT UNDERWENT A VALVE EXPLANT AFTER AN IMPLANT DURATION OF TEN (10) YEARS, TEN (10) MONTHS. UPON REVIEW OF SOURCE DOCUMENTATION, THE REASON FOR EXPLANT WAS DUE TO AORTIC STENOSIS AND REGURGITATION, SECONDARY TO CALCIFICATION. THE 27 MM BIOPROSTHESIS WAS REPLACED WITH A 25 MM BIOPROSTHESIS. THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE POST-OPERATIVE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290776 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R