BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1777151 · Received July 30, 2010

    Report

    Report Number
    2015691-2010-13793
    Event Type
    Death
    Date Received
    July 30, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 28, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION REGARDING THIS EVENT WAS LEARNED THROUGH THE OPERATIVE REPORT (FOR SURGERY OF (B) (6)2010) AND THE DISCHARGE SUMMARY RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1.83 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE DISCHARGE SUMMARY WAS RECEIVED. PER THE DISCHARGE SUMMARY, CVVH WAS STOPPED IN THE MORNING OF (B) (6)2010, AND THE PATIENT EXPIRED THAT AFTERNOON. THE FOLLOWING COMPLICATIONS WERE ALSO NOTED IN THE DISCHARGE SUMMARY: RESPIRATORY FAILURE; ACUTE RENAL FAILURE REQUIRING CVVH ON (B) (6)2010 (THOUGHT TO BE DUE TO ATN/SEPSIS/HEMODYNAMIC INSTABILITY); (B) (4); RAPID ATRIAL FIBRILLATION; DELIRIUM/AGITATION (THOUGHT TO BE MULTIFACTORIAL - ICU DELIRIUM, MEDS, SEPSIS); PNA/VAP/HAP; AND LGIB.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT WAS HAVING ISSUES WITH PRIMING. THE NURSE STATED SHE THOUGHT THE FRANGIBLES WERE GETTING CAUGHT IN THE LUER LOCK IMPEDING FLOW AND CAUSING AIR IN LINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-09M2833

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death