BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2810900 · Received October 31, 2012

    Report

    Report Number
    2015691-2012-18582
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION OR SAMPLE DEVICE IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE EXPLANT WAS DUE TO AORTIC STENOSIS SECONDARY TO CALCIFICATION. PER THE OP REPORT, THE PATIENT HAD FROZEN NONFUNCTIONING CALCIFIED PROSTHETIC VALVE. THE LEAFLETS ARE IMMOBILE. THE VALVE WAS EXCISED AND REPLACED WITH A 25 MM EDWARDS VALVE. IN ADDITIONAL THERE WAS A SMALL VSD AT THE SEPTUM WHICH WAS REPAIRED. OF NOTE, THE MITRAL VALVE WAS REPAIRED WITH 28 MM ANNULOPLASTY AND THE TRICUSPID VALVE WAS ALSO REPAIRED WITH A 34 MM RING ANNULOPLASTY. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS. TEE WAS PERFORMED AND REVEALED TO BE A NORMALLY FUNCTIONING BIOPROSTHETIC AORTIC VALVE. NO EVIDENCE OF ANY MITRAL OR TRICUSPID INSUFFICIENCY AND WELL MAINTAINED LEFT VENTRICULAR FUNCTION. THE PATIENT APPEARED TO TOLERATE THE PROCEDURE WELL. THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, THE SUBJECT DEVICE CANNOT BE ASSESSED FOR ANY DEFICIENCY. ALTHOUGH THE ROOT CAUSE CANNOT BE INVESTIGATED, THE REPORTED STENOSIS WAS LIKELY DUE TO THE "FROZEN NONFUNCTIONING CALCIFIED PROSTHETIC VALVE AND IMMOBILE LEAFLETS" NOTED IN THE OP REPORT. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 YEARS AND 6 MONTHS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R