BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3103612 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20047
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: AS STATED, MULTIPLE ATTEMPTS WITH THE HEALTHCARE PROVIDER (HCP) TO OBTAIN ADDITIONAL INFORMATION AND RECORDS HAVE BEEN UNSUCCESSFUL THE HOSPITAL RISK MANAGEMENT HAS DECLINED TO PROVIDE ANY ADDITIONAL EVENT DETAILS OR PATIENT RECORDS. MOREOVER, ATTEMPTS TO RETURN THE DEVICE IN QUESTION FOR EVALUATION HAVE ALSO BEEN DENIED BY THE HEALTHCARE PROVIDER. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THE DEVICE IN QUESTION PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT ADDITIONAL INFORMATION AND/OR DEVICE RETURN, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. EDWARDS WILL CONTINUE FOLLOW UPS WITH THE HCP AND WILL SUBMIT A SUPPLEMENTARY REPORT TO INCLUDE FINAL ANALYSIS AND CONCLUSIONS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED AN ADVERSE EVENT REPORT REGARDING AN EDWARDS AORTIC BIOPROSTHETIC VALVE, AS FOLLOWS: "27 PERICARDIAL BIOPROSTHESIS WAS PLACED AND UPON RESUMING CARDIAC ACTION, IT WAS NOTED THAT SIGNIFICANT CENTRAL AORTIC REGURGITATION WAS OCCURRING WHICH WAS NOT TOLERATED BY THE PT'S POOR VENTRICLE. THIS VALVE WAS REMOVED AND REPLACED WITH A #25 EDWARDS SUPRA-ANNULAR PORCINE PROSTHESIS WITHOUT ANY FURTHER LEAKAGE. DUE TO SEVERE ARRYTHMIAS, A VENOARTERIAL ECMO WAS PLACED. POST OPERATIVELY THE PT DEVELOPED HEMOPTYSIS AND HAD NEARLY NO CARDIAC FUNCTION. AN IMPELLA DEVICE WAS PLACED THE FOLLOWING DAY BUT THE PATIENT STILL SUFFERED VERY POOR FLOW. THE FAMILY MADE THE DECISION TO REMOVE LIFE SUPPORT AND THE PT EXPIRED." THIS EVENT WAS REPORTED BY THE CUSTOMER AND A VOLUNTARY USER FACILITY MEDWATCH ((B)(4)). MULTIPLE ATTEMPTS BY EDWARDS TO OBTAIN ADDITIONAL DETAILS AND RECORDS (OPERATIVE REPORT, DEATH SUMMARY, ECHO IMAGING, ECHO CDS...ETC) WERE DECLINED BY THE REPORTING HEALTHCARE PROVIDER. HOWEVER, THE HEALTHCARE PROVIDER HAS INDICATED THAT THERE IS NO ALLEGATION OF DEVICE MALFUNCTION OR QUALITY DEFICIENCY REGARDING THE EDWARDS REPLACEMENT PORCINE PROSTHESIS WHICH REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204624 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800TFX R-12M4382

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| L| R