BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1961949 · Received January 15, 2011

    Report

    Report Number
    2015691-2011-14690
    Event Type
    Injury
    Date Received
    January 15, 2011
    Date of Event
    September 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PANNUS. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE/ANNULOPLASTY RING. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES/ANNULOPLASTY RINGS IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

    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 7 YEARS AND 2 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL STENOSIS. ACCORDING TO THE OPERATIVE REPORT, THIS IS A (B)(6) WOMAN WHO 7 YEARS AGO HAD A MITRAL VALVE REPAIR FOR FUNCTIONAL MITRAL REGURGITATION AND TRICUSPID VALVE REPAIR FOR THE SAME. SHE ALSO HAD PULMONARY VEIN ISOLATION FOR ATRIAL FIBRILLATION. SHE DID WELL INITIALLY, BUT AGAIN RECENTLY DID HAVE SHORTNESS OF BREATH AND WAS FOUND THAT SHE HAD SEVERE MITRAL STENOSIS, RECURRENT TRICUSPID REGURG, AND ATRIAL FIBRILLATION HAD RECURRED. ON BYPASS, THE LEFT ATRIUM WAS OPENED ABOVE THE RIGHT SUPERIOR PULMONARY VEIN. THERE WAS SEVERE STENOSIS OF THE MITRAL VALVE RELATED TO THE SCAR TISSUE GROWING OVER THE PREVIOUSLY PLACED ANNULOPLASTY RING. THE ANNULOPLASTY RING WAS COMPLETELY EXCISED. AN EDWARDS 25 MM PERICARDIAL MAGNA EASE MITRAL VALVE WAS PLACED. ONCE OFF BYPASS, SHE WAS RETURNED TO THE INTENSIVE CARE UNIT IN GOOD CONDITION. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 3E0924

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention