MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-26 for RELIEVA STRATUS MICROFLOW SPACER BC1417RS manufactured by Acclarent.
[2707017]
Pt, who was on anticoagulants and aspirin therapy, underwent a hybrid surgical procedure, utilizing both acclarent balloon sinus dilation technology and traditional fess instruments. The physician implanted an acclarent frontal stratus in the sphenoid sinus, with off label triamcinolone, without incident. Four weeks later, the normally scheduled stratus explant occurred. During subsequent observation, the pt began to bleed from the nasal side where the stratus was removed. The pt's nose was packed and the pt admitted to the hosp. The pt was administered platelets and fresh frozen plasma to counter the bleeding. Three days later ,the pt was released. One week later, the pt was seen by the physician and was reported to be doing well. An add'l week later, the pt began to bleed again from the nose and was treated in the er; then readmitted to the hosp for observation. No other intervention was required. The device was not returned for eval.
Patient Sequence No: 1, Text Type: D, B5
[9975436]
During the pt's initial hosp admission for bleeding, it was learned that the pt had resumed his anticoagulant treatment (plavix) as instructed by his primary care physician. However, the pt choose to begin taking two daily adult aspirins instead of one baby aspirin. During the pt's second hosp admission, the treating physician noted an eschar along the pt's middle turbinate. The physician knew and stated that the use of the stratus in the sphenoid sinus and use of the triamcinolone was off label. It is speculated this may be the result of the stratus device lacerating the mucosa as it was being removed from the pt. No product malfunction was reported and outcome of the procedure was very good. Acclarent will continue to monitor this phenomenon for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00016 |
| MDR Report Key | 2639629 |
| Report Source | 05 |
| Date Received | 2012-06-26 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-06-01 |
| Date Added to Maude | 2012-07-06 |
| 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 Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875398 |
| 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 | STRATUS FRONTAL SPACER |
| Product Code | KAM |
| Date Received | 2012-06-26 |
| Model Number | NA |
| Catalog Number | BC1417RS |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-26 |