BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 1531409 · Received November 12, 2009

    Report

    Report Number
    3005172759-2009-00004
    Event Type
    Other
    Date Received
    November 12, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 9, 2009
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER OF THE FRONTAL SPACER, (B)(4), WAS REVIEWED. A REVIEW OF THE DEVICE HISTORY RECORD AND HISTORICAL TRENDING WAS PERFORMED. THE PRODUCT MET SPEC. WE WILL CONTINUE TO INVESTIGATE THIS COMPLAINT, IF THERE IS ANY RELEVANT INFO FOUND, A SUPPLEMENTAL MEDWATCH FORM WILL BE FILED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PT. ON (B)(6) 2009, THE PT HAD FUNCTIONAL ENDOSCOPIC SINUS SURGERY, IN WHICH BALLOON SINUSPLASTY DEVICES WERE USED TO DILATE BOTH FRONTAL SINUSES, ALONG WITH BILATERAL FRONTAL SINUS SPACER IMPLANTATION. ON (B)(6) 2009, 34 DAYS LATER, THE PHYSICIAN ATTEMPTED TO REMOVE THE FRONTAL SINUS SPACERS IN OFFICE, BUT WAS UNABLE TO VISUALIZE THEM. THE FRONTAL SPACER IFU IS ONLY APPROVED FOR 14 DAY IMPLANTATION. ON (B)(6) 2009, DAY 38, THE PT WAS TAKEN TO THE OPERATING ROOM TO REMOVE THE FRONTAL SPACERS UNDER FLUOROSCOPY. THE RIGHT FRONTAL SPACER WAS REMOVED WITHOUT ISSUE. THE LEFT WAS ALSO REMOVED, BUT WAS FOUND TO BE MISSING ONE OF THE RETENTION WINGS. THE RETENTION WING IS A SMALL COMPONENT OF THE SPACER MADE OF NITINOL. THIS COMPONENT IS L-SHAPED IN APPEARANCE, MADE FROM WIRE MEASURING .2 MM IN DIAMETER. AFTER FURTHER EXPLORATION DURING THE SAME SURGICAL PROCEDURE, THE DETACHED RETENTION WING WAS RETRIEVED. ON (B)(6) 2009, THE PHYSICIAN REPORTED THAT THE PT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPACER KAM ACCLARENT, INC. 090504A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R