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).
[19724607]
Simon et al. Use of intracranial stenting to secure unstable liquid embolic casts in wide neck sidewall intracranial aneurysms was published in operative neurosurgery. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: in this patient, after microcatheter removal, a small string protrusion or "tail" of onyx was present in the parent artery with cardiac-gated pulsations. In this case the onyx did not laminate or tack down to the endothelium, and unstable pulsatile string was thought to represent a long-term risk. Therefore, a 4. 5 x 37, enterprise vascular reconstruction device (vrd) was placed across the neck of the aneurysm and over the onyx string, securing it against the wall of the parent vessel. Patient awoke without symptoms. Information received from the same article as mfr#s 2029214-2015-00325, 2029214-2015-00331, 2029214-2015-00332.
Patient Sequence No: 1, Text Type: D, B5
[19866527]
Http://journals. Lww. Com/neurosurgery/fulltext/2011/08000/use_of_intracranial_stenting_to_secure_unstable. 59. Aspx. This report was created to capture complications described for patient one. The devices will not be returned for analysis as they were consumed in the event; therefore the event cause could not be determined. The lot history record review was not possible since the lot numbers were not reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00330 |
| MDR Report Key | 4659168 |
| 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 | 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. Required No Informationntervention | 2015-04-03 |