BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL SINUS IMPLANT

    MDR report key: 3631871 · Received January 10, 2014

    Report

    Report Number
    3010101669-2014-00001
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 10, 2014
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE WITH CHRONIC LYMPHOCYTIC LEUKEMIA DEVELOPED AN INVASIVE RIGHT SIDE FUNGAL SINUSITIS APPROXIMATELY 2 WEEKS AFTER ENDOSCOPIC SINUS SURGERY INCLUDING BILATERAL PLACEMENT OF PROPEL IMPLANTS. ENDOSCOPIC EXAMINATION AT WEEK 1 WAS UNREMARKABLE AND SINUSES APPEARED TO BE HEALING NORMALLY. PATIENT SUBSEQUENTLY DEVELOPED RIGHT-SIDED SINUS AND OCULAR PAIN AND WAS TREATED BY PRIMARY CARE PHYSICIAN WITH ANTIBIOTICS AND ORAL STEROIDS WITHIN 2 WEEKS OF SURGERY. PATIENT'S SYMPTOMS PERSISTED. SUBSEQUENT WEEKLY ENDOSCOPIC EXAMS INDICATED RECURRENT EDEMA THROUGHOUT THE RIGHT SINUS ANATOMY. THE IMPLANTS WERE REMOVED AT 2 WEEKS; MACROSCOPICALLY THERE WAS NO SIGN OF FUNGAL COLONIZATION. GIVEN PERSISTENCE OF ORBITAL PAIN, PATIENT WAS TAKEN BACK TO THE OPERATION ROOM FOR A DEBRIDEMENT AT WEEK 3. TISSUE SPECIMENS TAKEN FROM THE ETHMOID SINUS AND LAMINA PAPYRACEA TESTED POSITIVE FOR INVASIVE FUNGUS. CONDITION HAS BEEN TREATED WITH DUAL IV ANTIFUNGAL THERAPY AND ADDITIONAL SINUS DEBRIDEMENTS. AS THE PATIENT WAS IMMUNOCOMPROMISED AND HAD RECEIVED ORAL STEROIDS AND IV ANTIBIOTICS DURING POST-OP WEEK, THE EXACT ROOT CAUSE OF THE FUNGAL SINUSITIS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20634 PROPEL SINUS IMPLANT OWO INTERSECT ENT 70011 30815001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R