BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 3085133 · Received April 25, 2013

    Report

    Report Number
    3005172759-2013-00017
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADD'L INFO. TREATING SURGEON MENTIONED THAT THE SPACER HAD FUNCTIONED PROPERLY HAVING RESOLVED THE INITIAL SINUS PATHOLOGY. PER INSTRUCTION FOR USE, THE ACCLARENT STRATUS DEVICES ARE APPROVED FOR IMPLANTATION FOR A 14 DAYS PERIOD. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE LONG PERIOD OF IMPLANTATION OF ETHMOID SINUS SPACER MAY HAVE CONTRIBUTED TO THE FOREHEAD PAIN. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL, AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF AN EVENT OCCURRED ON (B)(6) 2013 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. THE TREATING SURGEON REPORTED THAT IN (B)(6) 2010, A COLLEAGUE OF HIS, INSERTED AN ACCLARENT ETHMOID SINUS STRATUS SPACER ON THE RIGHT SIDE OF ETHMOID SINUS. THERE WERE NO DIFFICULTIES REPORTED AND HE WAS UNAWARE OF THE INSERTION. THE PT RECENTLY WENT TO EMERGENCY ROOM COMPLAINING OF RIGHT FOREHEAD PAIN. THE TREATING SURGEON OBTAINED A CT SCAN THAT REVEALED THE SPACER MOSTLY IN THE ETHMOID SINUS, BUT PARTIALLY IN THE RIGHT MAXILLARY SINUS. THE TREATING SURGEON AND THE PT DECIDED TO REMOVE THE SPACER AND DILATE THE RIGHT FRONTAL SINUS UNDER ANESTHESIA ON (B)(6) 2013. THE ENTIRE ACCLARENT ETHMOID STRATUS SPACER WAS ABLE TO BE REMOVED INTACT AND NO FURTHER REPORTED SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179639 RELIEVA STRATUS MICROFLOW SPACER ETHMOID MICROFLOW SPACER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention