BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 2654320 · Received July 2, 2012

    Report

    Report Number
    3005172759-2012-00025
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 29, 2012
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K083574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) BEFORE (B)(6) 2012. ACCLARENT FOLLOWED UP ON THIS REPORT AND CONTACTED THE REPORTING PHYSICIAN. THE PHYSICIAN STATED THAT HE HAD NO EXPLANATION FOR THE STRATUS NOT BEING REMOVED SINCE HE WAS NOT THE SURGEON WHO PLACED THE DEVICE, AND HE DID NOT KNOW THE SURGEON WHO PERFORMED THE PROCEDURE. THE WAS NO SERIOUS ADVERSE EVENT OR ANY CONSEQUENCES FROM THE DELAYED REMOVAL OF THE STRATUS DEVICE. THE PHYSICIAN INDICATED THAT THE RECURRENCE OF POLYPS OR INFLAMMATION NOTED WAS NOT RELATED TO THE RETAINED DEVICE BUT RATHER THE NATURE OF THE DISEASE ITSELF. THE PHYSICIAN STATED ALL ACCLARENT DEVICES FUNCTIONED AS INTENDED AND THE DEVICE IN THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION AND ITS WHEREABOUTS IS UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSE. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT BEFORE A BALLOON SINUPLASTY PROCEDURE, HE IDENTIFIED AN ACCLARENT RELIEVA FRONTAL STRATUS DEVICE IN THE LEFT FRONTAL SINUS AREA, THAT THE PHYSICIAN BELIEVED WAS IMPLANTED BY ANOTHER PHYSICIAN (B)(6) AGO. THERE WAS SOME SWELLING AND INFLAMMATION SURROUNDING THE AREA. THE PHYSICIAN USED FORCEPS TO EXPLANT THE STRATUS DEVICE AND HE WAS ABLE TO DILATED THE SINUS EASILY WITH ACCLARENT BALLOON TECHNOLOGY. THE PHYSICIAN STATED THAT THERE HAS BEEN NOTHING UNUSUAL IN THE POSTOPERATIVE COURSE DURING THE FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPCER KAM ACCLARENT, INC. BC1417RS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other FORCEPS| ACCLARENT RELIEVA FRONTAL STRATUS