MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2015-06-19 for ONYX ANEURYSM manufactured by Irvine.
[18266106]
Citation: katrin van loock et al. Microsurgical removal of onyx hd-500 from an aneurysm for relief of brainstem compression. J neurosurg. 2010 oct;113(4):770-3. Doi: 10. 3171/2009. 10. Jns09668. The following report was received through review of literature: magnetic resonance imaging revealed an onyx mass was substantially compressing the right cerebral peduncle 5 years after a patient was treated with onyx hd-500. The patient was initially treated for large right (pcoa) posterior communicating artery aneurysm. Angiography confirmed the presence of an occluded (pcoa) aneurysm with mass effect. A decision was made to attempt partial resection of the onyx embolization material to alleviate the compression on the cerebral peduncle. The aneurysm distal neck was opened to remove the onyx mass compressing the cerebral peduncle, however the aneurysm was found to still be patent, filling with blood between the onyx mass and the aneurysm wall. The small hole in the aneurysm was glued with fibrin sealant to stop bleeding. The surgery was discontinued pending a balloon test occlusion of the right proximal carotid artery. The second surgery was performed on the same day as the balloon test occlusion. The aneurysm was opened distal to its neck. The onyx mass was dense, hard and impossible to remove with microsurgical scissors. Removal was attempted with high speed drill with a 1-mm fine diamond bit, but despite irrigation this gave rise to excessive heat and smoke and little process was made in removing the mass. An ultrasonic aspirator proved to be the ideal tool to resect the mass, fragmenting the onyx into smaller pieces and could therefore be removed by suction and microsurgical forceps. The onyx mass in general was not adherent to the aneurysm wall except for some minor adhesion near the neck of the aneurysm. The remnant of the aneurysm was clipped along its neck. Post-operative the patient experienced a headache but experienced a significant improvement on 3 month follow up of spasm. Angiography should complete occlusion of the right (pcoa) aneurysm. Magnetic resonance revealed adequate removal of onyx mass and the cerebral peduncle regained its original configuration.
Patient Sequence No: 1, Text Type: D, B5
[18437874]
Http://www. Ncbi. Nlm. Nih. Gov/pubmed/19895204. The onyx was not returned for evaluation as it was discarded. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown. The lot history record review was not possible since the lot number was not reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00711 |
| MDR Report Key | 4855518 |
| Report Source | 01,03 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-05-20 |
| Date of Event | 2010-10-01 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| 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 CA 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 | 2015-06-19 |
| 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. Required No Informationntervention | 2015-06-19 |