MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2015-04-03 for ONYX ANEURYSM manufactured by Irvine.
[5600706]
Citation: ronie peske et al. Evaluation of onyx hd-500 embolic system in the treatment of 84 wide neck intracranial aneurysms. Neurosurgery vol. 64 number 5. May 2009. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: sixty- nine patients with 84 aneurysms were treated. Most of the aneurysms were located in the anterior circulation (80 of 84 aneurysms), were unruptured (74 of 84 aneurysms), and were incidental. Ten presented with subarachnoid hemorrhage, and 15 were symptomatic. All aneurysms had wide necks (neck _4 mm and/or dome- to- neck ratio_1. 5). Fifty aneurysms were small (_12 mm), 30 were large (12 to _25 mm) and 4 were giant. Angiographic follow- up was available for 65 of the 84 aneurysms at 6 months, for 31 of the 84 aneurysms at 18 months, and for 5 of the 84 aneurysms at 36 months. Onyx leakage (onyx extravasation) occurred in 18 patients. It was mild in 10, moderate in six and severe in two. Internal carotid artery stenosis and thrombosis was seen in one patient (5 months after treatment). Severe internal carotid artery stenosis (50% of the lumen) occurred in four patients. Onyx extravasation was in two of these patients, and moderate extravasation occurred in one patient, there was no extravasation in one patient. At the clinical follow-up at 6 months, the mass effect was cured in four patients. There was partial improvement in two patients (optic nerve) and no change in three patients. (two with six nerve lesions and one with third nerve palsy). In two of these patients, the symptoms initially worsened (third and sixth cranial nerves), with regression to the previous state in 15 days in one patient and in 3 months in the other. Two patients developed a new cranial nerve deficit after treatment; 1 patient presented with new compression of the optic nerve with permanent visual deficiency, and the presented with temporary sixth nerve palsy. Of the aneurysms with optic nerve compression, only minor improvement was seen after embolization in both cases. Information received from the same article as mfr #s 2029214-2015-00317, 2029214-2015-00337.
Patient Sequence No: 1, Text Type: D, B5
[13037090]
Http://www. Ncbi. Nlm. Nih. Gov/pubmed/19404128. The lot history record review was not possible since the lot number was not reported. The onyx were not returned for analysis; therefore the event causes could not be determined. The events occurred in the patients during procedure and post procedure and their causes were unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00326 |
| MDR Report Key | 4659390 |
| Report Source | 01,03 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-05 |
| Date of Event | 2008-07-08 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-04-03 |
| 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 | MRS. TRICHA MILES |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801224 |
| Manufacturer G1 | IRVINE |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONYX ANEURYSM |
| Generic Name | POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL |
| Product Code | OBA |
| Date Received | 2015-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2015-04-03 |