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 2016-03-09 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[40031806]
The physician stated the implant was placed correctly, however the patient's anatomy may have contributed to the migration. In an abundance of caution, intersect ent is reporting this event as a malfunction based on the information received and the remote possibility of a serious injury should a similar event occur. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40031807]
The patient underwent revision endoscopic sinus surgery (ess) in (b)(6) 2016. Sinus implants were placed bilaterally, in previously modified anatomy, in the ethmoid sinuses without incident. Approximately one week post-surgery the implant on the right side had migrated to the patient's throat area; the left side implant remained in place. The patient felt something in their throat (described as a choking sensation) and concerned about a possible obstruction of the airway went to the er. The reporting physician stated that the patient coughed out the implant prior to receiving intervention while in the er; patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[43297089]
Voluntary event report (mw 5060385) which contained additional information was received on 3/24/2016. Additional narrative: the information provided in the initial report indicated that the patient visited er. Clinical quality, safety & risk specialist from the hospital confirmed the patient did not mention an er visit when reporting the event to them. Additionally, the hospital had no record of the patient receiving treatment in their er. Based on the lhr review, the product met all specifications. A potential root cause related to manufacturing / process control could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[43297090]
The patient underwent revision endoscopic sinus surgery (ess) (b)(6) 2015. Sinus implants were placed bilaterally, in previously modified anatomy, in the ethmoid sinuses without incident. Approximately one week post-surgery while the patient was driving, the implant on the right side had migrated to the patient's throat area; the left side implant remained in place. The patient reported to the hospital that he pulled off the freeway and removed the object from his throat manually and then proceeded to drive on to their post-operative appointment with the physician. Patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2016-00003 |
| MDR Report Key | 5490510 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-09 |
| Date of Report | 2016-02-10 |
| Date Mfgr Received | 2016-03-24 |
| Device Manufacturer Date | 2015-08-28 |
| Date Added to Maude | 2016-03-09 |
| 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 | 2016-03-09 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 50828001 |
| Device Expiration Date | 2017-08-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-03-09 |