MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-07-21 for RELIEVA STRATUS ETHMOID MICROFLOW SPACER BC1017RSZ manufactured by Acclarent, Inc..
[50118083]
No device was received for analysis at the time of submission of the initial 3500a. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50118084]
This is complaint is from a literature source. It was reported that a (b)(6) male patient underwent functional endoscopic sinus surgery 7 months ago for chronic rhinosinusitis with nasal polyposis with symptoms of chronic nasal congestion and headaches. Before surgery, placement of relieva stratus microflow spacer with use of steroids (off label) in conjunction with the stents was discussed with patients. However, the patient was told drug-eluting, nonabsorbable stents were not used during the procedure after surgery. The presence of the stents was not noted to patient on postoperative visit. Within two months of surgery, the patient was treated with multiple combinations of oral and topical therapies for regrowth of polyps and return of symptoms. Seven (7) month later, it was found that a foreign body consistent with a retained stent imbedded in the tissues of the sphenoethmoidal recess on the both sides. There was extensive chronically inflamed mucosal tissue diffusely, with more focal granulation tissue surrounding the device. The stents including the nitinol wings were removed on both sides. Injury to the orbits or skull base was avoided. Cultures of specimens taken from both left and right stents showed heavy growth of stenotrophomonas maltophilia and moderate growth of klebsiella oxytoca, coagulase negative staphylococcus, and beta-hemolytic streptococcus anginosus. Fungal cultures were negative. Postoperatively, the patient underwent nebulizer treatments with antibiotics, antifungals, and steroid solution twice daily. He was started on a 28-day course of levofloxacin because of the multiple bacteria that were isolated from his retained stents. At follow-up 10 days after the surgery, the patient had minimal postoperative pain or drainage. There was a moderate amount of crusting that was debrided and an adhesion on the left side that was lysed with a suction catheter. Debridement was repeated the following week and then again at 6 weeks with appropriately healing tissues and no evidence of polypoid regrowth. Other company's products were used during the same procedure: gelfilm (pfizer), merogel (medtronic xomed surgical products). Article title: retained drug-eluting stents and recalcitrant chronic rhinosinusitis: a case report. The objective of study was to report a newly described complication of retained drug-eluting stents from endoscopic sinus surgery for refractory rhinosinusitis. Model and catalog number of relieva stratus microflow spacer is not available. According to relieva stratus microflow spacer instruction for use: caution this device is not intended for use with an active drug substance. The safety and effectiveness of this device with an active drug substance in the reservoir have not been established. For example, use with steroids might result in serious adverse events due to high local and/or systemic concentrations. The safety and effectiveness of injecting solutions other than saline solution in the relieva stratus catheter have not been established.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2016-00013 |
| MDR Report Key | 5812502 |
| Report Source | LITERATURE |
| Date Received | 2016-07-21 |
| Date of Report | 2016-06-23 |
| Date of Event | 2013-04-02 |
| Date Added to Maude | 2016-07-21 |
| 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 | JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497899383 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS ETHMOID MICROFLOW SPACER |
| Generic Name | CANNULA, SINUS |
| Product Code | KAM |
| Date Received | 2016-07-21 |
| Catalog Number | BC1017RSZ |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-07-21 |