BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3021455 · Received March 26, 2013

    Report

    Report Number
    2015691-2013-19658
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION COULD NOT BE ASSESSED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE STENOSIS WAS LIKELY CAUSED BY THE CALCIFICATION. 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. IN THIS CASE, THE HEALTHCARE PROVIDER HAS INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. THE PATIENT'S OP REPORT DOCUMENTS A HISTORY OF AORTIC VALVE STENOSIS, AS WELL AS TYPE 2 DIABETES MELLITUS AND ATRIAL FIBRILLATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS AND 8 MONTHS DUE TO AORTIC STENOSIS WITH CALCIFICATION. PER THE OP REPORT, THIS IS AN (B)(6) GENTLEMAN WITH HISTORY OF MULTIPLE MEDICAL PROBLEMS INCLUDING HISTORY OF AORTIC VALVE STENOSIS, STATUS POST A BIOPROSTHETIC AORTIC VALVE REPLACEMENT (AVR) IN 2002. HE ALSO HAS A HISTORY OF TYPE 2 DIABETES MELLITUS, ATRIAL FIBRILLATION, HYPERTENSION, HYPERLIPIDEMIA, HYPOTHYROIDISM AND CORONARY ARTERY DISEASE WHO PRESENTED RECENTLY WITH SHORTNESS BREATH. CARDIAC CATHETERIZATION AND ECHOCARDIOGRAPHY REVEALED SEVERE PROSTHETIC AORTIC VALVE STENOSIS AND MODERATE CORONARY DISEASE IN THE LEFT ANTERIOR DESCENDING ARTERY WHICH WAS FELT TO BE HEMODYNAMICALLY SIGNIFICANT. THEREFORE, REDO-AVR WAS SCHEDULED. EXAMINATION OF THE AORTIC VALVE PROSTHESIS NOTED DENSE CALCIFICATIONS AND IMMOBILITY OF 2 OF THE 3 LEAFLETS. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. THERE WERE NO OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124475 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R