BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3813488 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01156
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 17, 2014
    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

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. 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. 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. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE LEAFLETS. THE FREE MARGINS OF LEAFLETS 2 AND 3 EXHIBITED MODERATE TO HEAVY CALCIFICATION. CUSTOMER REPORT OF CALCIFICATION WAS CONFIRMED AS CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT, INTO THE ORIFICE, AND AT THE STENT INFLOW. HEMATOMA WAS OBSERVED ON ALL THREE LEAFLETS. THE X-RAY DEMONSTRATED CALCIFICATION AND COMMISSURE 2 WIREFORM DISTORTION. COMMISSURE 2 WIREFORM AND WIREFORM NEAR COMMISSURE 3 WERE EXPOSED ON THE OUTFLOW ASPECT. THESE DAMAGES ARE MOST LIKELY DUE TO EXPLANT. X-RAY.

    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 MALE PATIENT UNDERWENT AN AORTIC VALVE EXPLANT AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TEN (10) MONTHS DUE TO STENOSIS SECONDARY TO HEAVY CALCIFICATION. THIS WAS REPLACED WITH A 23 MM PERICARDIAL BIOPROSTHESIS. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292053 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R