MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-20 for PIPELINE NV UNK PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184303782]
See related regulatory report 2029214-2020-00267. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184303783]
Griffin a, reese v, h? Seyinoglu z, et al. Predictors of clinical outcome after treatment of intracranial aneurysms with the pipeline embolization device.? World neurosurgery. 2019;130: e666-e671. Doi: 10. 1016/j. Wneu. 2019. 06. 185. Medtronic received a literature article pertaining to a study to identify predictors of adverse events associated with the pipeline. In this study the mean age was 56. 3, 80% female. The study took place between january 2014 and september 2018. 204 aneurysms in 170 patients were treated with the pipeline. 181 aneurysms were located in the anterior circulation, and 23 were found in the posterior circulation. 82% of aneurysms were saccular, followed by 11% fusiform and 4% blister. (11%). The mean aneurysm size was 8. 2mm. The neurologic mortality rate was 1. 8%, occurring in 3 patients, with deaths due to stroke, iph, or aneurysm rupture. The all-cause mortality was 2. 9%, occurring in 5 patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00268 |
| MDR Report Key | 9860861 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-20 |
| 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 | PIPELINE |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2020-03-20 |
| Model Number | NV UNK PIPELINE |
| Catalog Number | NV UNK PIPELINE |
| Lot Number | UNKNOWN |
| 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 | 1. Death | 2020-03-20 |