BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 1553726 · Received November 25, 2009

    Report

    Report Number
    3005172759-2009-00006
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    October 27, 2009
    Report Date
    November 24, 2009
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER OF THE FRONTAL SPACERS, (B)(4), WAS REVIEWED. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL TRENDING WAS PERFORMED. THE PRODUCT MET SPECIFICATION.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PT. THE PT HAD ENDOSCOPIC SINUS SURGERY INCLUDING BALLOON DILATION OF BILATERAL FRONTAL SINUSES AND PLACEMENT OF BILATERAL FRONTAL STRATUS DEVICES ON (B)(6) 2009. IN THE COURSE OF THE ENDOSCOPIC SINUS SURGERY, THE PHYSICIAN USED A SHAVER TO PERFORM TURBINATE REDUCTIONS AND REMOVE POLYPS AND OTHER TISSUE. THE PT RETURNED TO CLINIC TWO WEEKS POST-OPERATIVELY ON (B)(6) 2009, AT WHICH TIME THE RIGHT FRONTAL STRATUS DEVICE WAS REMOVED EASILY BUT THE LEFT FRONTAL STRATUS DEVICE WAS DIFFICULT TO VISUALIZE. ACCORDING TO THE PHYSICIAN, THERE WAS AN EXCESSIVE AMOUNT OF POST-OPERATIVE SWELLING IN THE LEFT FRONTAL RECESS, WHICH HE ATTRIBUTED TO THE USE OF THE SHAVER IN REMOVING TISSUE IN THAT REGION. BECAUSE, THE PT EXPERIENCED DISCOMFORT WHILE THE PHYSICIAN ATTEMPTED TO LOCATE AND REMOVE THE LEFT FRONTAL STRATUS DEVICE IN THE OFFICE, THE PHYSICIAN DECIDED TO REMOVE THE DEVICE IN THE OPERATING ROOM ON (B)(6) 2009. (B)(6) CONFIRMED THAT THE LEFT FRONTAL STRATUS DEVICE HAD NOT MIGRATED FROM ITS INITIAL POSITION. THE REMOVAL OF THE DEVICE IN THE OPERATING ROOM WAS NOTED TO BE EASY WITHOUT INCIDENT OR COMPLICATIONS. AS OF (B)(6) 2009, THE PT CONTINUES TO DO WELL WITH NO COMPLICATIONS OR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPACER KAM ACCLARENT, INC. 090710B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R