BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRTUS MICROFLOW SPACER

    MDR report key: 3229846 · Received July 10, 2013

    Report

    Report Number
    3005172759-2013-00026
    Event Type
    Other
    Date Received
    July 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHORS OF THE ARTICLE STATED THAT THE NASAL POLYPS, RECURRENCE OF DISEASE AND INCREASED BLEEDING WERE RELATED TO THE RETENTION OF THE ACCLARENT ETHMOID SPACER. VP OF MEDICAL AFFAIRS REVIEWED THE ARTICLE AND CONCLUDED THAT IT IS KNOWN THAT CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS CAN RECUR, ESPECIALLY IN THE FACE OF ASTHMA AND IT IS DIFFICULT TO KNOW WHAT PORTION OF THE REAPPEARANCE OF THE DISEASE WAS RELATED TO UNDERLYING CHRONIC RHINOSINUSITIS AND WHAT PORTION WAS RELATED TO THE RETAINED SPACER. THE ACCLARENT RELIEVA STRATUS MICROFLOW SPACER INSTRUCTIONS FOR USE (IFU) STATES (SECTION 8E), "THE RELIEVA STRATUS MICROFLOW SPACER MAY BE LEFT IN PLACE UP TO 14 DAYS." ALSO, THE INDICATIONS FOR USE STATE THAT THE "RELIEVA STRATUS MICROFLOW SPACER IS INDICATED FOR USE AS A POSTOPERATIVE SPACER TO MAINTAIN AN OPENING IN THE ETHMOID SINUSES WITHIN THE FIRST 14 DAYS FOLLOWING SURGERY." LEAVING THE SPACER FOR A LONGER PERIOD OF TIME REPRESENTS AN OFF-LABEL USE OF THE SPACER AND IS CONTRARY TO THE IFU. WHILE UNDERLYING NASAL POLYPOSIS, CRS, AND ASTHMA COULD HAVE PLAYED A ROLE IN THE RECURRENCE OF THE DISEASE, WITH THE INFORMATION AVAILABLE, IT IS PROBABLE THAT OFF-LABEL USE OF THE ACCLARENT RELIEVA STRATUS MICROFLOW SPACER DEVICE USED WITHOUT FOLLOWING THE IFU CONTRIBUTED TO THE INCREASED POLYP FORMATION, GRANULATION TISSUE AND INCREASED BLEEDING AT THE TIME OF REVISION SURGERY. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. 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 MADE AWARE OF THIS EVENT ON (B)(4) 2013, WHEN A LITERATURE SEARCH WAS BEING CONDUCTED BY AN ACCLARENT EMPLOYEE. THE AUTHORS REPORTED THAT AT THE TIME OF THE SURGERY AN ACCLARENT ETHMOID SPACER PLACEMENT WAS DISCUSSED WITH THE PT. AFTER THE SURGERY, THE FAMILY WAS TOLD THAT THE SPACER WAS NOT USED DURING THE PROCEDURE. THERE WAS RECURRENCE OF POLYPS AND SYMPTOMS WITHIN A FEW MONTHS AFTER SURGERY. THIS WAS NOT RESPONSIVE TO MEDICAL MANAGEMENT. A REVISION SURGICAL PROCEDURE WAS UNDERTAKEN. PREOPERATIVE COMPUTED TOMOGRAPHIC (CT) IMAGES RAISED A SUSPICION OF POSSIBLE RETAINED SPACERS FROM SURGERY 7 MONTHS BEFORE. AT THE TIME OF SURGERY, A FOREIGN BODY CONSISTENT WITH A RETAINED SPACER WAS IDENTIFIED AND NOTED TO BE EMBEDDED IN THE TISSUES OF THE SPHENO-ETHMOID RECESS OF THE LEFT SIDE. AFTER DISSECTION, THE SPACER WAS REMOVED IN ITS ENTIRETY. A SIMILAR APPROACH WAS USED TO REMOVE THE RETAINED DEVICE ON THE RIGHT SIDE. THE AUTHORS REPORTED THAT THERE WAS INCREASED BLEEDING WORSENED BY GRANULATION TISSUE AND INFECTION. POSTOPERATIVELY THE PT WAS TREATED WITH NEBULIZED ANTIBIOTICS, ANTIFUNGALS, AND STEROIDS. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316214 RELIEVA STRTUS MICROFLOW SPACER ETHMOID MICROFLOW SPACER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other