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 Irvine.
[17214958]
Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms. Neurosurgery 66 [ons suppl 1]:ons92-ons98, 2010. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: a patient with a smaller ventral variant aneurysm had successful occlusion with onyx, which was delivered with multiple cycles of balloon inflation, injection and reperfusion. After the microcatheter was removed, immediate angiography demonstrated that the onyx was migrating out of the aneurysm lumen. The balloon was re-inflated, pushing the cast back into the aneurysm. The balloon was left inflated for an additional 10 minutes in an attempt to secure the cast back into the aneurysm but this was unsuccessful. A vascular reconstruction device (vrd) was navigated across the inflated balloon overlying the aneurysm neck without difficulty. Onyx cast was secure. Information received from the same article as mfr report #s 2029214-2015-00330 2029214-2015-00331 2029214-2015-00331.
Patient Sequence No: 1, Text Type: D, B5
[17523937]
Http://journals. Lww. Com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable. 59. Aspx. This report was created to capture complications reported for patient number four. The lot history record review was not possible since the lot numbers were not reported. The devices will not be returned for analysis as they were consumed in the event; therefore the cause could not be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00325 |
| MDR Report Key | 4659280 |
| Report Source | 03 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-05 |
| Date of Event | 2010-03-01 |
| Date Mfgr Received | 2015-03-05 |
| 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 | 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 | 2015-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRVINE |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-03 |