BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3944864 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01632
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    May 31, 1977
    Report Date
    June 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 1992, DATE OF EVENT IS DATE OF JOURNAL ARTICLE PUBLICATION.

    Additional Manufacturer Narrative · 1

    CARPENTIER-EDWARDS (MODEL AND SERIAL NUMBER UNKNOWN). IMPLANTS BETWEEN MAY 1977 AND DECEMBER 1987. LOW OUTPUT SYNDROME, MULTISYSTEM FAILURE, HEMMORHAGE, MYOCARDIAL INFARCTION, PROLONGED COMA, GASTROINTESTINAL BLEEDING, RESPIRATORY FAILURE, CLINICAL VALVE DYSFUNCTION, ENDOCARDITIS, PRIMARY TISSUE FAILURE, PVL, PSEUDOANEURYSM. DEATH AND SERIOUS INJURY. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE(S) WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE(S), EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION(S). 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. (B)(4).

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION FROM JOURNAL ARTICLE, "USE OF THE CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS: ASSESSMENT OF A PATIENT SELECTION POLICY," Nº4 JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY; OCTOBER 1992: AN EDWARDS CARPENTIER BIOPROSTHESIS WAS IMPLANTED IN 369 PATIENTS (414 VALVES) BETWEEN MAY 1977 AND DECEMBER 1987. THERE WERE 242 AORTIC VALVE REPLACEMENTS, 80 MITRAL VALVE REPLACEMENTS, 44 MULTIVALVE REPLACEMENTS, 2 PATIENTS TRICUSPID VALVE REPLACEMENTS AND 1PULMONIC VALVE REPLACEMENT. IT WAS REPORTED THERE WERE 41 CASES OF EARLY DEATH DUE TO LOW OUTPUT SYNDROME (12), MULTISYSTEM FAILURE (10), PERIOPERATIVE DEATH (HEMORRHAGE (4) AND MYOCARDIAL INFARCTION (2)), HEMORRHAGE (3), PROLONGED COMA (2), GASTROINTESTINAL BLEEDING (1), RESPIRATORY FAILURE (1) AND OTHER (6), UNSPECIFIED. THIRTY-NINE LATE CARDIAC RELATED DEATHS WERE REPORTED: CHF (13), SUDDEN UNEXPECTED DEATH (22), CLINICAL VALVE DYSFUNCTION (1), POST-OPERATIVE DEATH AFTER REOPERATION FOR DYSFUNCTION (1) AND PROSTHETIC VALVE ENDOCARDITIS (2). EIGHT PATIENTS UNDERWENT REOPERATION DUE TO PRIMARY TISSUE FAILURE. VALVE WAS EXPLANTED FOR FOUR PATIENTS WITH FAILING AORTIC BIOPROSTHESIS AND 7 PATIENTS WITH FAILING MITRAL BIOPROSTHESIS (FATIGUE LEASIONS OF TEARS AND PERFORATIONS AND OBSTRUCTIVE CALCIFICATION), EXACT CAUSE OF FAILURE IS UNKNOWN. THERE WERE 5 CASES OF VALVE ENDOCARDITIS, AND 3 CASES OF PVL OR PSEUDOANEURYSM AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422221 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R