MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-23 for PROPEL SINUS IMPLANT 60011 manufactured by Intersect Ent.
[31966754]
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.
Patient Sequence No: 1, Text Type: N, H10
[31966755]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2015-00006 |
| MDR Report Key | 5243991 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-23 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-09-14 |
| Date Mfgr Received | 2015-11-05 |
| Date Added to Maude | 2015-11-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMY WOLBECK |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506412115 |
| Manufacturer G1 | INTERSECT ENT |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL SINUS IMPLANT |
| Generic Name | DRUG ELUTING STENT |
| Product Code | OWO |
| Date Received | 2015-11-23 |
| Model Number | 60011 |
| Catalog Number | 60011 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-23 |