BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2022758 · Received March 17, 2011

    Report

    Report Number
    2015691-2011-15042
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    November 3, 2010
    Report Date
    February 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THERE ARE SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE INVESTIGATED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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 6 YEARS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO STRUCTURAL DETERIORATION WITH AORTIC STENOSIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT IS A (B)(6) MALE WHO HAD UNDERGONE A CABG IN 1990 FOLLOWED BY A AVR IN 2005. HE WAS NOTED TO HAVE DEVELOPED STRUCTURAL DETERIORATION OF HIS BIOPROSTHETIC VALVE WITH AS. ECHO SHOWED CRITICAL AORTIC STENOSIS WITH RELATIVELY PRESERVED LV FUNCTION. CATH SHOWED PATENT GRAFTS INCLUDING LIMA TO LAD. IT WAS FELT, HE WAS A GOOD CANDIDATE FOR RE-DO AORTIC VALVE REPLACEMENT WITH TISSUE PROSTHESIS. THE PATIENT AND FAMILY UNDERSTOOD THE RISKS AND BENEFITS OF SURGERY AND AGREED TO PROCEED AS PLANNED. THE PREVIOUS PROSTHETIC AORTIC VALVE WAS EXCISED BY DIVIDING ALL SUTURES AND REMOVING PREVIOUS PLEDGET MATERIAL. THE ANNULUS WAS DIBRIDED. THE ANNULUS WAS SIZED TO A 23MM CARPENTIER-EDWARDS MAGNA EASE BOVINE PERICARDIAL VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION.

    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 4K1637

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention