BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEE H10

    MDR report key: 3945121 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01638
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. TYPE OF REPORTABLE EVENT: DEATH AND SERIOUS INJURY. METHOD: DEVICES NOT RETURNED/DEVICES REMAIN IMPLANTED. THE DEVICES WERE NOT RETURNED TO EDWARDS FOR ANALYSIS AND THERE WAS NO PATIENT SPECIFIC INFORMATION PROVIDED IN THE ARTICLE. WITHOUT RETURN OF THE DEVICES, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ARTICLE: ¿LONG-TERM OUTCOME OF THE CARPENTIER-EDWARDS PERICARDIAL VALVE IN THE AORTIC POSITION IN JAPANESE PATIENTS¿ PUBLISHED BY CIRCULATION JOURNAL VOL.78 APRIL 2014. DOI (CIRC J 2014; 78: 882 ¿ 889). BACKGROUND: ACCORDING TO THE JAPANESE CIRCULATION SOCIETY GUIDELINES, A BIOPROSTHESIS IS RECOMMENDED FOR AORTIC VALVE REPLACEMENT (AVR) IN PATIENTS AGED = 65 YEARS WHO HAVE NO RISK FACTORS FOR THROMBOEMBOLISM. THERE ARE FEW DATA, HOWEVER, REGARDING THE ACTUAL DURABILITY OF BIOPROSTHETIC VALVES IN JAPANESE PATIENTS. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE LONG-TERM DURABILITY OF CARPENTIER-EDWARDS PERICARDIAL (CEP) VALVES IN JAPANESE AVR PATIENTS, AND TO ASSESS THE RISK FACTORS FOR REOPERATION DUE TO STRUCTURAL VALVE DETERIORATION (SVD). CONCLUSIONS: THE DURABILITY OF CEP VALVES IN PATIENTS WITH AVR WAS EXCELLENT, ESPECIALLY IN ELDERLY PATIENTS. THUS, IT SEEMS APPROPRIATE TO FOLLOW THE CURRENT JAPANESE CIRCULATION SOCIETY RECOMMENDATIONS FOR THE USE OF BIOPROSTHETIC VALVES. EDWARDS RECEIVED THE ABOVE ARTICLE IN WHICH THERE WERE 26 IN-HOSPITAL PATIENT DEATHS, 18 DEATHS THAT OCCURRED 30 DAYS POST-OPERATIVELY, AND 24 LATE DEATHS ATTRIBUTED TO VALVE-RELATED ISSUES. LATE COMPLICATIONS INCLUDED 8 EVENTS OF PROSTHETIC VALVE ENDOCARDITIS AND 38 EVENTS OF THROMBOEMBOLISM. EIGHTEEN EVENTS REQUIRED RE-OPERATION DUE TO STRUCTURAL VALVE DETERIORATION AND ONE EVENT REQUIRED RE-OPERATION DUE TO PARAVALVULAR LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421601 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R