BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 1509946 · Received October 19, 2009

    Report

    Report Number
    2015691-2009-11857
    Event Type
    Injury
    Date Received
    October 19, 2009
    Date of Event
    June 4, 2009
    Report Date
    September 24, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO DEVICE WAS RETURNED FOR EVALUATION.

    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%).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER A IMPLANT DURATION OF 119 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 8K1330

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention