BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1571021 · Received January 6, 2010

    Report

    Report Number
    2015691-2010-12435
    Event Type
    Injury
    Date Received
    January 6, 2010
    Date of Event
    November 6, 2009
    Report Date
    December 11, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT'S 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

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2010. IT WAS REPORTED THAT DURING PREP, FOR A DRUG ELUTING STENTING TREATMENT PROCEDURE, SHAFT DAMAGE OCCURRED. THE PHYSICIAN NOTICED A TECHNICAL DEFECT ON THE STENT. "THE STENT WAS INSERTED INTO THE GUIDING CATHETER." IT WAS INDICATED THAT "THE TECHNICAL DEFECT WAS AROUND 10CM FROM THE OPERATOR¿S PART ON THE HYPOTUBE SHAFT." THE STENT WAS NOT DEPLOYED AND DID NOT REACH THE PATIENT'S CORONARY ARTERY. THE PROCEDURE WAS STOPPED AND THE PATIENT CONDITION IS EXCELLENT. HOWEVER, PRODUCT ANALYSIS REVEALED HYPOTUBE BREAK.

    Description of Event or Problem · 1

    PT WITH ANTI-E FAILED TO REACT WITH ANY OF THE E POSITIVE CELLS ON THE PANEL. ACCOUNT DESCRIBES REACTIVITY WITH SCREENING CELLS AS 2+. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-08J2014

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention