BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 2803289 · Received November 13, 2009

    Report

    Report Number
    3005172759-2009-00005
    Event Type
    Other
    Date Received
    November 13, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 12, 2009
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE LOT NUMBER OF THE FRONTAL SPACERS WAS NOT AVAILABLE. THREE POSSIBLE LOTS, 090223A, 090102A, AND 90408D WERE AVAILABLE TO THE FACILITY. THE MANUFACTURE DATE FOR THOSE THREE LOTS WERE 02/23/2009, 01/02/2009, AND 04/08/2009, RESPECTIVELY. THE EXPIRATION DATES FOR THOSE LOTS ARE 02/2011, 01/2011, AND 04/2011, RESPECTIVELY. A REVIEW OF THE THREE DEVICE HISTORY RECORDS THAT PERTAINED TO THOSE LOTS, ALONG WITH HISTORICAL TRENDING, WAS PERFORMED. ALL THREE LOTS OF PRODUCT MET SPECIFICATION.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PATIENT. ON (B)(6) 2009, THE PATIENT HAD FUNCTIONAL ENDOSCOPIC SINUS SURGERY, IN WHICH BALLOON SINUPLASTY DEVICES WERE USED TO DILATE BOTH FRONTAL SINUSES, ALONG WITH BILATERAL FRONTAL SINUS SPACER IMPLANTATION. THE PATIENT HAD CHRONIC SINUSITIS INCLUDING EXTENSIVE POLYPOSIS. THE POLYPS WERE REMOVED AT THE TIME OF THE SURGERY BY FORCEPS AND POWERED INSTRUMENTATION. ON (B)(6) 2009, THE PHYSICIAN REMOVED THE LEFT FRONTAL SPACER IN OFFICE, BUT WAS UNABLE TO VISUALIZE THE RIGHT SPACER. AN X-RAY WAS OBTAINED, SHOWING THAT THE RIGHT FRONTAL SPACER DEVICE WAS WITHIN THE RIGHT FRONTAL SINUS. THE PHYSICIAN ELECTED TO KEEP THE SPACER IN PLACE, AS HE FELT THE DEVICE WAS WORKING AND PROVIDING BENEFIT TO THE PATIENT. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2009 TO REMOVE ADDITIONAL FRONTAL SINUS POLYPS, AS WELL AS TO REMOVE THE RIGHT FRONTAL STRATUS DEVICE. IN THE OPERATING ROOM, THE LOCATION OF THE FRONT STRATUS DEVICE WAS CONFIRMED BY C-ARM FLUOROSCOPY. THE PHYSICIAN WAS UNABLE TO EXTRACT THE FRONTAL STRATUS DEVICE ENDOSCOPICALLY, AND DECIDED TO DRILL A SMALL HOLE ABOVE THE EYEBROW AND THEN INSERTED AN ENDOSCOPIC CATHETER INTO THE FRONTAL SINUS TO EXTRACT THE FRONTAL STRATUS DEVICE. THIS TECHNIQUE WAS SUCCESSFUL. THE PATIENT EXPERIENCED NO COMPLICATIONS OR SEQUELA TO THE SUCCESSFUL DEVICE REMOVAL. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2009 AND CONTINUES TO FEEL FINE. THE PHYSICIAN SUSPECTS THAT THE DEVICE WAS NOT PLACED PROPERLY BEFORE BEING DEPLOYED. IN ADDITION, TO BETTER LOCATE THE DEVICE, THE PHYSICIAN STATED THAT HE WILL START CUTTING THE SHAFT OF THE SPACER MORE PROXIMALLY, TO LEAVE A LONGER PIECE IN PLACE FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPACER KAM ACCLARENT, INC. 090223A, 090102A, 090408D

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R