BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2042720 · Received April 6, 2011

    Report

    Report Number
    2015691-2011-15156
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    March 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED 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 REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 1/2 YEARS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO AORTIC STENOSIS. ACCORDING TO THE OPERATIVE REPORT, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED SEVERE DEGENERATIVE PROSTHETIC AORTIC VALVE STENOSIS WITH MODERATE AORTIC REGURGITATION SECONDARY TO LEAFLET CONTRACTION AND FIXATION. THERE WAS NO EVIDENCE OF ENDOCARDITIS. UPON REMOVAL, IT WAS NOTED THAT THE VALVE LEAFLETS WERE CALCIFIED. THE VALVE WAS EXCISED AND THE ANNULUS WAS AGGRESSIVELY DEBRIDED OF RESIDUAL PLEDGETS. ANOTHER EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED. POST-OPERATIVE TEE DEMONSTRATED NORMAL BIOPROSTHETIC LEAFLET MOBILITY, NO EVIDENCE OF PERIVALVULAR LEAK, AND BASELINE VENTRICULAR FUNCTION.

    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 2E0850

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention