MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-25 for RELIEVA STRATUS MICROFLOW SPACER BC1017RS manufactured by Acclarent, Inc..
[3348853]
Acclarent was notified on (b)(6) 2013 of an event occurred on (b)(6) 2013 during a sinus surgical case when acclarent balloon dilation technology were used. The treating surgeon reported that in (b)(6) 2010, a colleague of his, inserted an acclarent ethmoid sinus stratus spacer on the right side of ethmoid sinus. There were no difficulties reported and he was unaware of the insertion. The pt recently went to emergency room complaining of right forehead pain. The treating surgeon obtained a ct scan that revealed the spacer mostly in the ethmoid sinus, but partially in the right maxillary sinus. The treating surgeon and the pt decided to remove the spacer and dilate the right frontal sinus under anesthesia on (b)(6) 2013. The entire acclarent ethmoid stratus spacer was able to be removed intact and no further reported sequelae.
Patient Sequence No: 1, Text Type: D, B5
[10688091]
Acclarent followed up on this report to gather add'l info. Treating surgeon mentioned that the spacer had functioned properly having resolved the initial sinus pathology. Per instruction for use, the acclarent stratus devices are approved for implantation for a 14 days period. Vp of medical affairs concluded that the long period of implantation of ethmoid sinus spacer may have contributed to the forehead pain. The subject device of this report was not returned for eval, and its whereabouts are unk. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2013-00017 |
| MDR Report Key | 3085133 |
| Report Source | 05 |
| Date Received | 2013-04-25 |
| Date of Report | 2013-03-28 |
| Date of Event | 2013-03-28 |
| Date Mfgr Received | 2013-03-28 |
| Date Added to Maude | 2013-05-07 |
| 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 | MONICA BARRETT |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874948 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS MICROFLOW SPACER |
| Generic Name | ETHMOID MICROFLOW SPACER |
| Product Code | KAM |
| Date Received | 2013-04-25 |
| Model Number | NA |
| Catalog Number | BC1017RS |
| Lot Number | UNK |
| ID Number | NA |
| 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 | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-25 |