MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2015-03-30 for ONYX ANEURYSM manufactured by Covidien (irvine).
[5578612]
Citation: h. Saruhan cekirge et al. Late angiographic and clinical follow-up results of 100 consecutive aneurysms treated with onyx recontruction: larges single center experience. Neuroradiology (2006) 48: medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: a total of 100 aneurysms in 94 patients were treated with endovascular onyx packing. Intracranial stenting was used adjunctively in 25 aneurysms including 19 during initial treatment and 6 during retreatment. The patient? S age ranged between 6 and 71 years with a mean of 41 years. All of the aneurysms were located at the internal carotid artery except in one patient who had a basilar tip and superior cerebellar artery aneurysms. Complete occlusion was achieved in 90 out of 100 aneurysms treated. Procedure /device related adverse events resulted in permanent neurological deficit in eight patients. Among these, two patients resulted in dependent survival (mrs 4), one having total opthalmoplegia and the other developed right middle cerebral artery infarct 3 days after treatment; caused left arm after stent/onyx treatment. The remaining six transient neurological adverse events (6. 4%) resolved completely. As for cranial nerve palsies, 15 patients presented with oculomotor palsies. In 11 of these the condition had completely resolved and 2 showed improvement at the 12 month follow up.
Patient Sequence No: 1, Text Type: D, B5
[13094341]
Article website: http://link. Springer. Com/article/10. 1007%2fs00234-005-0007-6. The onyx will not be returned for evaluation as they were consumed in the events. The lot history record review was not possible since the lot numbers were not reported. Based on the reported information, there did not appear to have been any defect of the devices during use. Nerve damage. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24362990]
Common device name: polymerizing, neurovascular embolization material. Procode: oba. Pma h060003. Reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00315 |
| MDR Report Key | 4642599 |
| Report Source | 01,03 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-05 |
| Date of Event | 2005-05-20 |
| Date Mfgr Received | 2015-05-05 |
| Date Added to Maude | 2015-03-30 |
| 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 CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801224 |
| 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 ANEURYSM |
| Generic Name | POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL |
| Product Code | OBA |
| Date Received | 2015-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-03-30 |