MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2013-07-10 for RELIEVA STRTUS MICROFLOW SPACER BC1017RS manufactured by Acclarent, Inc..
[3686285]
Acclarent was made aware of this event on (b)(4) 2013, when a literature search was being conducted by an acclarent employee. The authors reported that at the time of the surgery an acclarent ethmoid spacer placement was discussed with the pt. After the surgery, the family was told that the spacer was not used during the procedure. There was recurrence of polyps and symptoms within a few months after surgery. This was not responsive to medical management. A revision surgical procedure was undertaken. Preoperative computed tomographic (ct) images raised a suspicion of possible retained spacers from surgery 7 months before. At the time of surgery, a foreign body consistent with a retained spacer was identified and noted to be embedded in the tissues of the spheno-ethmoid recess of the left side. After dissection, the spacer was removed in its entirety. A similar approach was used to remove the retained device on the right side. The authors reported that there was increased bleeding worsened by granulation tissue and infection. Postoperatively the pt was treated with nebulized antibiotics, antifungals, and steroids. The pt is reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
[11039303]
The authors of the article stated that the nasal polyps, recurrence of disease and increased bleeding were related to the retention of the acclarent ethmoid spacer. Vp of medical affairs reviewed the article and concluded that it is known that chronic rhinosinusitis with nasal polyposis can recur, especially in the face of asthma and it is difficult to know what portion of the reappearance of the disease was related to underlying chronic rhinosinusitis and what portion was related to the retained spacer. The acclarent relieva stratus microflow spacer instructions for use (ifu) states (section 8e), "the relieva stratus microflow spacer may be left in place up to 14 days. " also, the indications for use state that the "relieva stratus microflow spacer is indicated for use as a postoperative spacer to maintain an opening in the ethmoid sinuses within the first 14 days following surgery. " leaving the spacer for a longer period of time represents an off-label use of the spacer and is contrary to the ifu. While underlying nasal polyposis, crs, and asthma could have played a role in the recurrence of the disease, with the information available, it is probable that off-label use of the acclarent relieva stratus microflow spacer device used without following the ifu contributed to the increased polyp formation, granulation tissue and increased bleeding at the time of revision surgery. This report is being submitted in an abundance of caution. 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 | 3005172759-2013-00026 |
| MDR Report Key | 3229846 |
| Report Source | 03 |
| Date Received | 2013-07-10 |
| Date of Report | 2013-06-19 |
| Date Mfgr Received | 2013-06-19 |
| Date Added to Maude | 2013-07-25 |
| 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 STRTUS MICROFLOW SPACER |
| Generic Name | ETHMOID MICROFLOW SPACER |
| Product Code | KAM |
| Date Received | 2013-07-10 |
| 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. Other | 2013-07-10 |