MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-04-01 for ONYX ANEURYSM manufactured by Covidien (irvine).
[19404240]
Citation: simon et al. Endovascular treatment of side wall aneurysms using a liquid embolic agent: a us single-center prospective trial. Neurosurgery 67:855-860, 2010 doi: 10. 1227/01. Neu. 0000374772. 22745. C3. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: during treatment of a left superior hypophyseal aneurysm in a patient, too much onyx hd-500 was injected before inflation of the balloon protection. There was premature embolization of the onyx, which exited the ophthalmic segment aneurysm. One small fragment (approximately 1mm) was identified in the middle cerebral artery angular artery. Injection was halted, and abciximab was administered. Due to these events and the inexperience with onyx hd-500 at that time the procedure was aborted and the aneurysm was embolized with guglielmi detachable coil (gdc). The patient awoke from the procedure with decreased vision in her left eye and mild right hand weakness without drift. At 6-month follow-up, her weakness had resolved, but her vision persisted.
Patient Sequence No: 1, Text Type: D, B5
[19779041]
Article website: http://journals. Lww. Com/neurosurgery/abstract/2010/09000/endovascular_treatment_of_side_wall_aneurysms. 37. Aspx. The lot history record review was not possible since the lot numbers were not reported. The onyx was not returned for analysis as they were consumed in the event; therefore, the event causes could not be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00323 |
| MDR Report Key | 4649471 |
| Report Source | 03 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-05 |
| Date of Event | 2010-09-01 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-04-01 |
| 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 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 | 2015-04-01 |
| 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. Required No Informationntervention; 2. Deathisabilit | 2015-04-01 |