MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-10 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[17391773]
A (b)(6) year old male with chronic lymphocytic leukemia developed an invasive right side fungal sinusitis approximately 2 weeks after endoscopic sinus surgery including bilateral placement of propel implants. Endoscopic examination at week 1 was unremarkable and sinuses appeared to be healing normally. Patient subsequently developed right-sided sinus and ocular pain and was treated by primary care physician with antibiotics and oral steroids within 2 weeks of surgery. Patient's symptoms persisted. Subsequent weekly endoscopic exams indicated recurrent edema throughout the right sinus anatomy. The implants were removed at 2 weeks; macroscopically there was no sign of fungal colonization. Given persistence of orbital pain, patient was taken back to the operation room for a debridement at week 3. Tissue specimens taken from the ethmoid sinus and lamina papyracea tested positive for invasive fungus. Condition has been treated with dual iv antifungal therapy and additional sinus debridements. As the patient was immunocompromised and had received oral steroids and iv antibiotics during post-op week, the exact root cause of the fungal sinusitis is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2014-00001 |
| MDR Report Key | 3631871 |
| Report Source | 05 |
| Date Received | 2014-01-10 |
| Date of Report | 2014-01-10 |
| Date of Event | 2013-12-01 |
| Date Mfgr Received | 2013-12-12 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-02-19 |
| 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 | 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 | 2014-01-10 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 30815001 |
| Device Expiration Date | 2014-08-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-01-10 |