BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1514663 · Received October 23, 2009

    Report

    Report Number
    2015691-2009-11914
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    August 18, 2009
    Report Date
    September 25, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    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), THE OPERATIVE REPORT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER IMPLANT DURATION OF ZERO DAYS. ON 10/02/2009 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED FROM THE OPERATIVE REPORT THAT THE DEVICE WAS EXPLANTED, DUE TO A "PLEDGETED SUTURE, WHICH HAD TORN LOOSE."

    Description of Event or Problem · 1

    PATIENT #4 FROM LITERATURE: L.G. CLOSE, A.K. HSU, S. RICKERT, M. SHRIME, A. TABAEE (2006). SYNECHIA FORMATION AFTER ENDOSCOPIC SINUS SURGERY AND MIDDLE TURBINATE MEDIALIZATION WITH AND WITHOUT FLOSEAL. AMERICAN JOURNAL OF RHINOLOGY(2007) 21:174-179. SUMMARY OF ARTICLE FROM ABSTRACT: THIRTY-SEVEN PATIENTS UNDERWENT MEDIALIZATION WITH PLACEMENT OF FLOSEAL. A STATISTICALLY SIGNIFICANT HIGHER INCIDENCE OF SYNECHIA FORMATION WAS NOTED IN PATIENTS WHO UNDERWENT MIDDLE TURBINATE MEDIALIZATION WITH THE PLACEMENT OF FLOSEAL (18.9%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-09E1159

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention