BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPEL SINUS IMPLANT

    MDR report key: 6431483 · Received March 24, 2017

    Report

    Report Number
    3008301917-2017-00006
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 18, 2017
    Report Date
    February 22, 2017
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    UDI-DI
    M927700110
    PMA / PMN Number
    P100044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO DESCRIBE EVENT OR PROBLEM (B5) INITIAL REPORT -THE PATIENT'S BILATERAL OCCULAR EDEMA WAS SIGNIFICANTLY REDUCED WITHIN 2 HOURS OF REMOVAL. CORRECTED REPORT DESCRIPTION - THE PATIENT'S BILATERAL PERIORBITAL EDEMA WAS SIGNIFICANTLY REDUCED WITHIN 2 HOURS OF REMOVAL. ADDITIONALLY CLARIFIED THE ALLERGIC REACTION TO THE IMPLANTS WAS TO THE MOMETASONE FUROATE ON THE SURFACE OF THE IMPLANTS. REFERENCE 3008301917-2017-00005 FOR FIRST IMPLANT OF BILATERAL CASE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT REVISION SINUS SURGERY WHICH INCLUDED BILATERAL TOTAL ETHMOIDECTOMY AND MAXILLARY ANTROSTOMY FOLLOWED BY PLACEMENT OF 1 DRUG-ELUTING SINUS IMPLANT INTO EACH ETHMOID SINUS. PATIENT PRESENTED POST OP DAY 3 AND 4 WITH BI-LATERAL PERIORBITAL EDEMA, SEVERE PAIN AND BLURRED VISION. POST OP DAY 4 CT SCAN CONDUCTED SHOWED NO DAMAGE TO ORBIT AND NO INFECTIONS. BASED ON THE CLINICAL PICTURE, NEGATIVE CT SCAN AND PHYSICAL EXAM FINDINGS, THE PHYSICIAN CONCLUDED THAT THE MOST LIKELY CAUSE OF THE PATIENT'S SYMPTOMS WAS AN ALLERGIC REACTION TO THE MOMETASONE FUROATE ON THE SUFACE OF THE IMPLANTS AND REMOVED BOTH. THE PATIENT'S BILATERAL PERIORBITAL EDEMA WAS SIGNIFICANTLY REDUCED WITHIN 2 HOURS OF REMOVAL. THE PHYSICIAN REPORTS DURING HIS FOLLOW-UP VISIT, THE PATIENTS' SYMPTOMS WERE COMPLETELY RESOLVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT DENIED ANY PREVIOUS DRUG ALLERGIES PRE-OPERATIVELY AND UPON PRESENTATION WITH SYMPTOMS POSTOPERATIVELY, DENIED BEING ALLERGIC TO MOMETASONE FUROATE (NASONEX). HOWEVER, THE PATIENT SUBSEQUENTLY REMEMBERED THAT HE HAD PREVIOUSLY EXPERIENCED EDEMA WHEN USING NASONEX. BASED ON THE CLINICAL PRESENTATION, THE RESOLUTION OF THE SYMPTOMS UPON REMOVAL OF THE IMPLANTS AND THE ADDITIONAL MEDICAL HISTORY INDICATIVE OF AN ALLERGY TO MOMETASONE FUROATE, IT IS THE TREATING PHYSICIAN'S MEDICAL OPINION THAT THE PATIENT SUFFERED AN ALLERGIC REACTION TO THE MOMETASONE FUROATE ON THE SURFACE OF THE IMPLANTS. THE INSTRUCTIONS FOR USE STATES THAT THE USE OF THE SINUS IMPLANT IS CONTRAINDICATED IN PATIENTS WITH SUSPECTED OR CONFIRMED INTOLERANCE TO MOMETASONE FUROATE. THE PATIENT'S WEIGHT IS NOT KNOWN TO THE MANUFACTURER. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS NOT RETURNED TO THE MANUFACTURER. 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. REFERENCE 3008301917-2017-00005 FOR FIRST IMPLANT OF BILATERAL CASE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION SINUS SURGERY WHICH INCLUDED BILATERAL TOTAL ETHMOIDECTOMY AND MAXILLARY ANTROSTOMY FOLLOWED BY PLACEMENT OF 1 DRUG-ELUTING SINUS IMPLANT INTO EACH ETHMOID SINUS. PATIENT PRESENTED POST OP DAY 3 AND 4 WITH BILATERAL PERIORBITAL EDEMA, SEVERE PAIN AND BLURRED VISION. POST OP DAY 4 CT SCAN CONDUCTED SHOWED NO DAMAGE TO ORBIT AND NO INFECTIONS. BASED ON THE CLINICAL PICTURE, NEGATIVE CT SCAN AND PHYSICAL EXAM FINDINGS, THE PHYSICIAN CONCLUDED THAT THE MOST LIKELY CAUSE OF THE PATIENT'S SYMPTOMS WAS AN ALLERGIC REACTION TO THE IMPLANTS AND REMOVED BOTH. THE PATIENT'S BILATERAL OCULAR EDEMA WAS SIGNIFICANTLY REDUCED WITHIN 2 HOURS OF THE REMOVAL. THE PHYSICIAN REPORTS DURING HIS FOLLOW-UP VISIT, THE PATIENTS' SYMPTOMS WERE COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212982 PROPEL SINUS IMPLANT PROPEL SINUS IMPLANT OWO INTERSECT ENT 70011 60707001 M927700110

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R