BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 1713706 · Received May 28, 2010

    Report

    Report Number
    3005172759-2010-00007
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ACCLARENT INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE HISTORICAL DATA DEMONSTRATES AN OVERALL COMPLAINT RATE OF 0.016% FOR COMPLAINTS RELATED TO FRONTAL SPACER WING DETACHMENT. NO DEVICE(S) WERE AVAILABLE FOR RETURN. THE SPECIFIC LOT WAS NOT AVAILABLE; HOWEVER, A RANGE OF LOTS AVAILABLE TO THE FACILITY WAS DETERMINED. LOT HISTORY RECORD REVIEW WAS PERFORMED ON LOTS 090223A, 090311A, AND 090402A. ALL THREE POSSIBLE LOTS MET SPECIFICATION AND WERE NOTED TO BE MANUFACTURED PRIOR TO PROCESS IMPROVEMENTS PUT IN PLACE TO REDUCE WING DETACHMENT. CAPA (B)(4) WAS OPENED TO INVESTIGATE THE FAILURE MODE OF "DETACHED RETENTION WING." IN ADDITION, AN UPDATED SPACER MPI FOR OPTIMIZED PROCESS BECAME ACTIVE ON (B)(4) 2009. TO DATE, NO WING DETACHMENTS HAVE OCCURRED IN LOTS MANUFACTURED BEYOND THE PROCESS IMPROVEMENTS. NOTE, THE MICROFLOW SPACER (FRONTAL) IS INDICATED FOR USE AS A POSTOPERATIVE SPACER TO MAINTAIN AN OPENING TO THE FRONTAL SINUSES WITHIN THE FIRST 14 DAYS FOLLOWING SURGERY, AS STATED IN THE IFU. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PATIENT ON (B)(6) 2010. ACCLARENT'S AWARENESS OF THIS EVENT WAS ALSO (B)(4) 2010. A FRONTAL STRATUS MICROSPACER WAS IMPLANTED ON (B)(6) 2010 AS PART OF A REPEAT SURGERY TO TREAT A PATIENT WITH REOCCURRING RESTENOSIS. AFTER 57 DAYS OF PLANNED TIME FOR IMPLANTATION, THE SPACER WAS REMOVED. UPON OBSERVATION, THE SPACER WAS NOTED TO BE MISSING A RETENTION WING. THE RETENTION WING IS A SMALL NON-INFLAMMATORY COMPONENT OF THE SPACER MADE OF NITINOL. THIS COMPONENT IS L-SHAPED IN APPEARANCE, MADE FROM WIRE MEASURING APPROXIMATELY 0.2 MM IN DIAMETER. THE PHYSICIAN NOTED THAT GRANULATION TISSUE WAS PRESENT, WHICH IS SUSPECTED TO HAVE CONTRIBUTED TO GREATER REMOVAL FORCE. THE PHYSICIAN ALSO NOTED THAT THE DETACHED WING WAS EMBEDDED IN MUCOSA. ACCLARENT'S (B)(4) WAS NOTIFIED OF THE EVENT, AND HAS BEEN IN CONTACT WITH THE APPLICABLE ENT CONSULTANT. AS OF (B)(6) 2010, THE PATIENT WAS NOTED TO BE FREE OF ANY COMPLICATIONS OR ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other