MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT; DRUG ELUTING STENT

Model Number 60011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Herpes (1898); Pain (1994)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

The surgeon hypothesized that due to the placement of the drug eluting implant during his sinus procedure the patient's immune system was weakened by the systemic absorption of mometasone furoate making them susceptible to the latent virus outbreak.To our knowledge, this is the first case of herpes zoster that has been reported following placement of the implant.It is known that herpes zoster (hz) or shingles is the most common manifestation of latent varicella zoster virus reactivation, which occurs naturally as a result of aging or in immunocompromised patients.It affects approximately 10-30% of the population.Disseminated herpes zoster has been reported in immune-compromised patients such as patients on cancer chemotherapy, hiv infection, and systemic corticosteroid therapy, as well as uncontrolled diabetic patients.Disseminated herpes zoster is rare in otherwise healthy persons who are not on immunosuppressive drugs and have no underlying malignancy.Propel placed in direct contact with the sinus mucosa delivers 370 mcg of mometasone furoate to the tissue over approximately 30 days.The lack of systemic exposure from propel was evaluated by (b)(4) (2011), who reported plasma concentration below the quantification limit of 30 pg/ml through 30 days.Furthermore, the steroid-releasing sinus implant with 1350 mcg of mometasone furoate (dose equivalent of approximately 4 propel sinus implants) was shown to have negligible systemic exposure by (b)(4) (2014), who reported plasma concentration below or near the quantification limit through 30 days.The systemic safety of the steroid-eluting sinus implants was further supported by the absence of adverse events typically associated with corticosteroid use including hypothalamic-pituitary-adrenal (hpa) axis suppression.The highly localized and controlled delivery of 370-1350 mcg of mometasone furoate over an extended period of time appears to eliminate the risk of hpa axis suppression, which naturally responds to the addition of exogenous steroids by reducing cortisol secretion.In conclusion, the amount of steroid released by the sinus implant during the first 30 days appears to be sufficient to exert a significant therapeutic effect without any systemic effect nor hpa axis suppression.Given the shingle etiology and the negligible systemic exposure and the absence of hpa axis suppression from mometasone furoate it is unlikely that the implant could compromise the patient immune system and trigger the occurrence of shingles in a patient.Even though there is strong clinical evidence that the device was not contributory intersect ent is conservatively reporting this event out of an abundance of caution.The following is being provided as this device is a combination product: c1: name: propel, c2: dose, frequency & route used: (1) 370 ug implant, c4: diagnosis for use: sinus surgery.Pma 510(k): combination product -yes.

Event Description

The patient underwent endoscopic sinus surgery (ess); the sinus implants were placed bilaterally in the ethmoid sinuses.Post operatively (approximately 2 weeks) the patient presented with unilateral eye pain (left side).The surgeon's initial impression was that the patient was experiencing sinusitis and prescribed oral steroid, however he believes the steroid was never taken.The patient was referred to an ophthalmologist and sent to the emergency room the same day.The emergency room physician noted a herpes outbreak on the patients' scalp, left forehead and peri-orbital area.The ophthalmologist diagnosed the patient with herpes zoster ophthalmicus and prescribed eyedrops to protect the patients' cornea.After a couple of weeks the patients symptoms resolved.

• Brand Name: PROPEL SINUS IMPLANT
• Type of Device: DRUG ELUTING STENT
• Manufacturer (Section D): INTERSECT ENT; menlo park CA
• Manufacturer (Section G): INTERSECT ENT; 1555 adams dr; menlo park CA 94025
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025 ; 6506412115
• MDR Report Key: 5243991
• MDR Text Key: 31966754
• Report Number: 3010101669-2015-00006
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 60011
• Device Catalogue Number: 60011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR