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 2016-02-04 for PROPEL MINI SINUS IMPLANT 60011 manufactured by Intersect Ent.
[37535624]
The propel mini sinus implant is intended for use in patients 18 years of age or greater following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids. The propel mini sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema. During the investigation, the physician's opinion was that because the patient did not have middle turbinates due to prior surgeries, this resulted in the implants sitting against the septum leading to septal perforation due to pressure necrosis through mucosa and cartilage. The radial force exerted by the implant is orders of magnitude smaller than the force required to produce fractures in the nasal septum (lee m, et. Al. Ohns (2010) 143, 784-788). The radial force decreases over time and there are no sharp edges to be pushed into/through the septum. Additionally, based on the company's evaluation and consistent with the reported information from the physician, there does not appear to be any device malfunction. Thus, it is highly unlikely that the implants caused or contributed to the septal perforation in this case. Given this patient's history of chronic sinusitis with persisting nasal polyposis and multiple prior sinus surgeries, it is more likely that the septal perforation resulted from surgical trauma, chronic obstructive polyposis, or the chronic use of topical nasal corticosteroids sprays. However, in the opinion of the treating physician, the device contributed to the adverse event, thus intersect ent is reporting this event out of an abundance of caution. 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.
Patient Sequence No: 1, Text Type: N, H10
[37535745]
The patient underwent a revision endoscopic sinus surgery (ess) on (b)(6) 2015; sinus implants were placed bilaterally in the ethmoid sinuses. During a post-surgical follow-up visit on (b)(6) 2015, the physician reported a posterior septal perforation apparent near the deployed implants. The physician reported on (b)(6) 2015 that no intervention was required at this time; she plans to monitor/observe the perforation. (as implants were placed bilaterally, the manufacturer is filing a report for each: please refer to mfr # 3010101669-2016-00001 for report on the other implant).
Patient Sequence No: 1, Text Type: D, B5
[43664089]
Patient Sequence No: 1, Text Type: N, H10
[43664090]
The patient underwent a revision endoscopic sinus surgery (ess) on (b)(6) 2015; sinus implants were placed bilaterally in the ethmoid sinuses. During a post-surgical follow-up visit on (b)(6) 2015 the physician reported a posterior septal perforation apparent near the deployed implants. The physician reported on (b)(6) 2015 that no intervention was required at this time; she plans to monitor/observe the perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2016-00002 |
| MDR Report Key | 5411863 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-04 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2016-12-18 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2016-02-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 MINI SINUS IMPLANT |
| Generic Name | DRUG ELUTING STENT |
| Product Code | OWO |
| Date Received | 2016-02-04 |
| Model Number | 60011 |
| Catalog Number | 60011 |
| Lot Number | 50526001 |
| Device Expiration Date | 2016-11-26 |
| 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 | 1. Deathisabilit | 2016-02-04 |