BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL SINUS IMPLANT

    MDR report key: 5040130 · Received August 28, 2015

    Report

    Report Number
    3010101669-2015-00005
    Event Type
    Injury
    Date Received
    August 28, 2015
    Report Date
    August 2, 2015
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    UDI-DI
    M927700110
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO CONTACT THE PHYSICIAN TO REQUEST ADDITIONAL DETAILS IN REGARD TO THIS EVENT, NO RESPONSE WAS RECEIVED. THE PHYSICIAN INDICATED THAT THE PATIENT NEEDS REVISION SURGERY; HOWEVER, IT IS UNKNOWN AT THIS TIME, WHETHER THE PATIENT HAS HAD REVISION SURGERY OR HAS RECEIVED ANY OTHER TREATMENT. MIDDLE TURBINATE LATERALIZATION IS A CONDITION THAT MAY OCCUR POST-SINUS SURGERY AND IS NOT LIKELY TO CAUSE ANY DETRIMENTAL EFFECT IN PATIENTS. IT MAY IMPAIR VISUALIZATION OF THE SINUS CAVITY OR IF MORE SEVERE MAY OBSTRUCT NASAL DRAINAGE INCREASING THE CHANCE OF SINUS INFECTIONS, HOWEVER WILL NOT IMPAIR BREATHING. THUS, IT IS NOT LIKELY THAT MT LATERALIZATION WILL CAUSE OR CONTRIBUTE TO PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE IMPLANT IS INTENDED TO BE USED IN CONJUNCTION WITH STANDARD POST-ESS CARE, PATIENT MANAGEMENT IS AT THE PHYSICIAN'S DISCRETION. DUE TO THE LIMITED INFORMATION THE COMPANY IS TAKING A CONSERVATIVE APPROACH IN REPORTING THIS EVENT. DATE OF THE EVENT: (B)(6) 2015. THE FOLLOWING IS BEING PROVIDED AS THIS DEVICE IS A COMBINATION PRODUCT: NAME: PROPEL, DOSE, FREQUENCY & ROUTE USED: (1) 370 UG IMPLANT, DIAGNOSIS FOR USE: SINUS SURGERY. COMBINATION PRODUCT -YES.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOSCOPIC SINUS SURGERY (ESS) INCLUDING BILATERAL TOTAL FULL ETHMOIDECTOMY, FRONTAL SINUSOTOMY, AND INFERIOR TURBINATE RESECTION, RESULTING IN A SIGNIFICANT TISSUE REMOVAL. THE SINUS IMPLANT WAS PLACED IN THE ETHMOID SINUS BILATERALLY PER INSTRUCTIONS FOR USE (IFU). PHYSICIAN INSTRUCTED THE PATIENT TO ROUTINELY IRRIGATE. NO POST-OPERATIVE VISITS WERE SCHEDULED. THE PATIENT RETURNED TO SEE THE PHYSICIAN 15 DAYS POST-OPERATIVELY. THE PHYSICIAN REPORTED THAT THE IMPLANT WAS NOT PRESENT, AND THE MIDDLE TURBINATE (MT) HAD SCARED TO THE LATERAL NASAL WALL BILATERALLY. THE IMPLANT MIGHT HAVE PREMATURELY MIGRATED AND BEEN EXPELLED. THE PATIENT HAS BEEN SET UP FOR REVISION SURGERY. (REFER TO MFR REPORT # 3010101669-2015-00004 FOR OTHER IMPLANT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570924 PROPEL SINUS IMPLANT DRUG ELUTING SINUS STENT OWO INTERSECT ENT 70011 50409004 M927700110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other