MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-02-16 for ONYX HD manufactured by Covidien (irvine).
[5441604]
Information received from the article: johnson et al. Optic pathway infarct after onyx hd 500 aneurysm embolization: visual pathway ischemia from superior hypophyseal artery occlusion. J neurointervent surg 2014;6:e47. Treatment of an incidentally discovered small wide necked aneurysm measuring 7mm located in the superior hypophyseal segment of the left ica (internal carotid artery). The patient was given dual antiplatelet therapy. Post off-label procedure, it was reported, the patient experienced a right incongruous homonymous hemianopia, and mri (magnetic resonance imaging) revealed an infarct of the ipsilateral optic chiasm/tract but no evidence of aneurysm mass effect or embolic cortical infarcts. The optic pathway ischemia is believed to be secondary to onyx penetration and occlusion of an sha (superior hypophyseal artery) branch near the aneurysm neck. Of note, the patient described in this report was treated prior to the widespread availability of flow diverting stents in the usa. In conclusion to the article, caution is advised when using liquid embolic agents to treat sha aneurysms as sha occlusion may lead to visual deficits. Onyx embolization of sha aneurysms or other aneurysms near small critical arteries should be avoided and alternative treatment techniques pursued.
Patient Sequence No: 1, Text Type: D, B5
[12891693]
The report was created to capture the post procedure complication that occurred for the patient. All the information was received from the article: johnson et al. Optic pathway infarct after onyx hd 500 aneurysm embolization: visual pathway ischemia from superior hypophyseal artery occlusion. J neurointervent surg 2014;6:e47. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00148 |
| MDR Report Key | 4519479 |
| Report Source | 03 |
| Date Received | 2015-02-16 |
| Date of Report | 2015-01-19 |
| Date Mfgr Received | 2015-01-19 |
| Date Added to Maude | 2015-02-17 |
| 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 | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801558 |
| Manufacturer G1 | COVIDIEN (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 HD |
| Generic Name | POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL |
| Product Code | OBA |
| Date Received | 2015-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN (IRVINE) |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-02-16 |