MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-02-17 for ONYX manufactured by Covidien (irvine).
[15900328]
Information received from the article: ashour et al. Onyx hd-500 for embolization of cerebral aneurysms. Neurological research. 2014 vol 36 no 4. Treatment of an aneurysm. It was reported that during one embolization procedure, onyx was seen herniating proximally into the lumen of the parent artery and the patient suffered a symptomatic anterior thalamoperforator territory infarct. The article the information was received from was created to review indications for, technical principles of, and complications and outcomes after onyx aneurysm embolization.
Patient Sequence No: 1, Text Type: D, B5
[16063716]
The report was created to capture the complication caused by the device migration. All the information was received from the article: ashour et al. Onyx hd-500 for embolization of cerebral aneurysms. Neurological research. 2014 vol 36 no 4. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00157 |
| MDR Report Key | 4521790 |
| Report Source | 03 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-01-19 |
| Date of Event | 2014-04-01 |
| 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 | 0 |
| 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 |
| Generic Name | POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL |
| Product Code | OBA |
| Date Received | 2015-02-17 |
| 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 | 2015-02-17 |