MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2015-04-03 for ONYX ANEURYSM manufactured by Covidien (irvine).
[5601838]
Citation: ronie peske et al. Evaluation of onyx hd-500 embolic system in the treatment of 84 wide neck intracranial aneurysms. Neurosurgery vol. 64 number 5. May 2009. Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review: clinical complications included two deaths related to the procedure (none of these were incidental aneurysms). A patient was treated 48 hours after sah (subarachnoid hemorrhage) (fisher grade 3, hh grade iv), without receiving antiplatelet before or after the procedure. Four hours later, neurological and clinical deterioration prompted a head computed tomographic scan, which showed extensive ipsilateral edema and hypodensity, and dsa, which showed ipsilateral internal carotid artery thrombosis. Successful recanalization was achieved with balloon angioplasty and intravenous administration of reppro. The patient died 9 days later as a result of extensive ipsilateral recurrent strokes and sepsis. All procedures were performed under general anesthesia, continuous cardiorespiratory monitoring, and invasive arterial pressure monitoring. Information received from the same article as mfr report #s 2029214-2015-00326 2029214-2015-00337
Patient Sequence No: 1, Text Type: D, B5
[13037600]
Http://www. Ncbi. Nlm. Nih. Gov/pubmed/19404128 this report was created to capture the death related to the onyx. The device was not returned for analysis, as it was 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 | 2029214-2015-00317 |
| MDR Report Key | 4659408 |
| Report Source | 01,03 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-05 |
| Date of Event | 2008-07-08 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-04-06 |
| 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 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. Death; 2. Other; 3. Required No Informationntervention | 2015-04-03 |