MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-05-12 for ONYX ANEURYSM 105-8101-500 manufactured by Covidien (irvine).
[5797583]
(b)(4). The following report was received by medtronic (covidien) through review of literature: patient's ages ranged from 35-85 years with a mean age of 57. The following adverse events were experienced following the procedure using onyx hd-500 (ev3). Worsening of preexisting cranial neuropathies (oculomotor deficit) was found in two patients, transient visual disturbance in one patient, transient ischemic attack (tia) in one patient. Two patients with subarachnoid hemorrhage (sah) had complications following the procedure that were due to their primary disease 1 grade iv patient required hemicraniectomy. There were two subarachnoid hemorrhage (sah) patients that were eventually discharged to inpatient rehabilitation facilities with permanent disabilities. Three patients had minor unintentional embolic migration into the parent artery without flow limitation.
Patient Sequence No: 1, Text Type: D, B5
[13289579]
(b)(4). This report was created to capture the serious injuries related to the onyx. The onyx will not be returned for evaluation as they were consumed in the events. Based on the reported information, there did not appear to have been any defects of the devices during use. The events occurred in the patients post procedure and their causes were unknown. The lot history record review was not possible since the lot number was not reported. (b)(4). Information received from the same article as mfr: 2029214-2015-00515.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029214-2015-00537 |
| MDR Report Key | 4767187 |
| Report Source | 03 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-04-13 |
| Date of Event | 2011-10-27 |
| Date Mfgr Received | 2015-04-13 |
| Date Added to Maude | 2015-05-12 |
| 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 | 0 |
| 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 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 | 2015-05-12 |
| Model Number | 105-8101-500 |
| 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 | 2015-05-12 |