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 2016-05-11 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[45005525]
The surgeon reported the implant was correctly positioned (aligned to the anterior edge of the middle turbinate). There was no repositioning/adjustment of the implants after placement. The implant was well opposed to sinus mucosa. The following is being provided as this device is a combination product: name: propel, dose, frequency & route used: (1) 370 ug implant, diagnosis for use: sinus surgery. Combination product -yes. Age, weight, lot number are unknown.
Patient Sequence No: 1, Text Type: N, H10
[45005526]
The patient underwent endoscopic sinus surgery (ess) and concomitant septoplasty with septal splints to treat chronic sinusitis with nasal polyps. Sinus implants were placed bilaterally in the ethmoid sinuses without incident. Septal splints (trimmed) were placed anterior to the middle turbinate after placement of the sinus implants. It is unknown whether the septal splints contacted the sinus implants. Within 12 hours of surgery, the patient felt "discomfort" in the back of his throat and went to the er. Upon examination by the ent physician on call, it was reported that the implant from the right side had migrated to the back of the patient's throat. The left side implant remained in place. The er physician removed the implant through the patient's oral cavity. The patient was seen by the surgeon one week post-op and reported to have experienced no harm from the migration and subsequent removal of the implant. The surgeon indicated that it is plausible that the septal splints could have potentially caused the dislodgement of the sinus implant. The patient is reportedly doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2016-00004 |
| MDR Report Key | 5649020 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-16 |
| Date of Event | 2016-04-06 |
| Date Mfgr Received | 2016-04-16 |
| Date Added to Maude | 2016-05-11 |
| 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 SINUS STENT |
| Product Code | OWO |
| Date Received | 2016-05-11 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | UNK |
| 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 | 2016-05-11 |