MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-17 for ONYX AVM 105-7000-060 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[189088401]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[189088402]
Medtronic received a report that the onyx liquid embolic was not clear in the fluoroscopic image. The speed setting was at 8 and shaken for 40 minutes. The vials did not sit for more than 5 minutes prior to injection, and the physician injected the onyx immediately after mixing. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-op angiographic results were good. The patient was undergoing surgery for treatment of a dural arteriovenous fistula (davf). It was noted the patient's vessel tortuosity was moderate. Ancillary devices include a fubuki 8fr, envoy da 6fr, apollo microcatheter, chikai guidewire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00149 |
| MDR Report Key | 9718548 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-04-16 |
| Date Added to Maude | 2020-02-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| 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 AVM |
| Generic Name | AGENT, INJECTABLE, EMBOLIC |
| Product Code | MFE |
| Date Received | 2020-02-17 |
| Model Number | 105-7000-060 |
| Catalog Number | 105-7000-060 |
| Lot Number | A815960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |