MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-21 for DRUG-ELUTING SINUS STENT manufactured by Intersect Ent.
[78126864]
Although, the medical reviewer believed the event was not device-related, the event is being reported to be conservative. Intersect ent is reporting this event as an adverse event based on the information received and the remote possibility the complication was caused by use of the implant rather than merely correlated with its placement. Orbital cellulitis is an uncommon complication of sinusitis. Orbital complications from surgery typically occur intraoperatively or in the immediate postoperative period. The treating physician indicated that other than the radiographic appearance of the patient's sinuses, the patient's sinus exam did not seem to match the severity of her orbital symptoms. The instructions for use lists infection as a potential risk associated with use of the steroid-eluting sinus implant(s). The patient's weight is not known to the manufacturer. The physician could not recollect the model of the device used, was either propel (model 70011) or propel mini (model number 60011). Date of the implant was approximately 3 to 3? Weeks prior to the event. The following is being provided as this device is a combination product: name: propel or propel mini; dose, frequency and route used: (1) 370 ug implant; diagnosis for use: sinus surgery. Combination product -yes. Reference mfr report number 3008301917-2017-00010 for second implant in this bilateral case.
Patient Sequence No: 1, Text Type: N, H10
[78126865]
Patient underwent bilateral total sphenoethmoidectomy, maxillary antrostomy as well as balloon sinuplasty of the frontal sinuses. Bilaterally steroid-eluting sinus implants were placed in the ethmoid cavities. Bioresorbable nasal packing product was placed within the implant on each side. No polyps or infection were encountered during surgery. Blood loss was minimal and the surgery was uneventful. Postoperatively, the patient was on 10 days of oral antibiotics and twice daily saline irrigations. Postoperative appointments were planned weekly. The first appointment reportedly went well. The patient missed her second appointment. Approximately 3 to 3? Weeks postoperatively the patient presented to the emergency room with right eye swelling, a ct was obtained and patient was diagnosed with a right preseptal orbital cellulitis. It was noted that the patient reported that her nose and sinuses felt very good. Endoscopy performed showed no clear evidence of mucopurulence or infection, there was no violation of the lamina, and the implants looked fine, with no evidence of adherent crusting. The patient improved rapidly on intravenous antibiotics and was eventually discharged to home without further medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2017-00009 |
| MDR Report Key | 6659336 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-21 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-21 |
| 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 | 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 |
| Generic Name | DRUG-ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2017-06-21 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | 1555 ADAMS DR MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-06-21 |