MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-01-30 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[5565207]
A patient underwent endoscopic sinus surgery in which drug eluting sinus implants were placed post-operatively bilaterally. The pt received an iv dose of decadron (8-10 mg) intra-operatively. No topical steroids were prescribed to the pt post-operatively. Between the surgery and the 1 week post-op appointment the pt had scheduled a routine visit to ophthalmologist. The pt was exhibiting no symptoms at the time of the visit, however, was informed by the ophthalmologist of increased intra-ocular pressure (iop). The ophthalmologist prescribed eye drops (type unk). At the 1 week post-op visit with the surgeon, the stents were removed. The physician did not have info regarding the iop levels prior to the surgery nor the level seen by the ophthalmologist. Additionally, the physician reported there were no complications or pre-existing condition prior to the surgery, which could contribute to the increased iop. The reporting physician believed that the pt's iop had returned to normal levels. Based on the info available, it is unk if the device contributed to the pts reported effect. However, out of an abundance of caution, the company is submitting this report. Refer to mdr 3010101669-2015-00002 for the report on the second implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2015-00001 |
| MDR Report Key | 4478401 |
| Report Source | 05,07 |
| Date Received | 2015-01-30 |
| Date of Report | 2014-12-31 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-31 |
| Device Manufacturer Date | 2014-09-17 |
| Date Added to Maude | 2015-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY WOLBECK |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506412115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2015-01-30 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 40917003 |
| ID Number | M92770011 |
| Device Expiration Date | 2016-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-01-30 |