MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-04-03 for ONYX ANEURYSM manufactured by Covidien (irvine).
[5598457]
Citation: dr. Mr r reynolds. Hemorrhagic complications after prasugrel(effient) therapy for vascular neuro-interventional procedures. Published in j neurointervent surg on may 3, 2012. Medtronic (covidien) received information through literature review and the following event was captured as a result of the review: hemorrhage was observed in one patient treated with onyx aneurysm embolization. Patient was given aspirin and clopidogrel. Information received from the same article as mfr# 2029214-2015-00340.
Patient Sequence No: 1, Text Type: D, B5
[13046608]
(b)(4). This report was created to capture complications related to the onyx. The onyx was not returned for evaluation as it was consumed in the event. The lot history record review was not possible since the lot number was not reported. Based on the reported information, there did not appear to have been any defect of the onyx during use; therefore its cause was unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00338 |
| MDR Report Key | 4659425 |
| Report Source | 03 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-06 |
| Date of Event | 2012-05-03 |
| Date Mfgr Received | 2015-03-06 |
| 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 CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801224 |
| Manufacturer G1 | COVIDIEN (IRVINE) |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE 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 | COVIDIEN (IRVINE) |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-03 |