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.
[78129972]
Bacteremia is exceedingly rare in chronic sinusitis. The instructions for use list infection as a potential risk associated with use of the steroid-eluting sinus implant(s). In an abundance of caution, intersect ent is reporting this event as an adverse event based on the information we received and the remote possibility the complication was caused by use of the implant rather than merely correlated with its placement the patient's weight is not known to the manufacturer. Date of the event was approximately 3? Weeks post operatively. The physician could not recollect the model of the device used, was either propel (model 70011) or propel mini (model number 60011). The following is being provided as this device is a combination product: name: propel or propel mini, dose, frequency & route used: (1) 370 ug implant, diagnosis for use: sinus surgery. Combination product -yes. Reference mfr report number 3008301917-2017-0007 for first implant in this bilateral case.
Patient Sequence No: 1, Text Type: N, H10
[78129973]
Patient underwent bilateral total ethmoidectomy and maxillary antrostomy during which bilateral 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 oral antibiotics for 10 days and twice daily saline irrigations. Postoperative appointments occurred weekly. The first two appointments were reported to be uneventful and included endoscopy and debridement, the implants were left in place. At the third postoperative appointment, the patient reported feeling poorly. The examining physician noted pus in the sinuses, worse on the right. Cultures were obtained and grew non-resistant staphylococcal species. The patient was started on augmentin. Subsequently, approximately 3? Weeks postoperatively, the patient presented to the emergency room and reportedly appeared toxic. A ct was obtained and showed diffuse inflammation in the operated sinuses, but no evidence of orbital wall dehiscence, or paranasal abscess formation. Blood cultures were obtained (eventually grew staphylococcal species), the patient was admitted and placed on iv antibiotics. The patient improved and discharged to home without further medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2017-00008 |
| MDR Report Key | 6659334 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-21 |
| Date of Report | 2017-05-25 |
| 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 |