MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-21 for PIPELINE FA-77375-20 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184413904]
See related regulatory report 2029214-2020-00273 and 2029214-2020-00274. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184413905]
Wang, j. , jia, l. , duan, z. , wang, z. , yang, x. , zhang, y. , & lv, m. (2019). Endovascular treatment of large or giant non-saccular vertebrobasilar aneurysms: pipeline embolization devices versus conventional stents.? Frontiers in neuroscience,? 13, 1. This study was performed to retrospectively analyze the safety and efficacy of a flow diverter in treating large and giant non-saccular aneurysms. The study took place between january 2014 and june 2018, with 11 female patients and 31 male patients. The complete occlusion rate was 90. 2%, the mrs score was 0 to 2, excellent in 97. 5% of patients. One patient with an aneurysm size of 21. 2 mm had a sudden severe headache 1 day post procedure. A subarachnoid hemorrhage was confirmed by ct scan, showing a hunt-hess scale of 2. The last mrs score was 1. Another patient with an aneurysm size of 23. 1 mm died from severe brainstem compression 3 days post procedure. The last mrs score was 6. The last patient with an aneurysm size of 25. 6 mm died from severe brain stem compression 2 days post procedure. The last mrs score was 6. Occlusion was seen with 4 patients, aneurysm enlargement in 1 patient, poor clinical outcome in 2 patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00275 |
| MDR Report Key | 9863624 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-21 |
| Date of Report | 2020-03-21 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-21 |
| 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 | 2020-03-21 |
| Model Number | FA-77375-20 |
| Catalog Number | FA-77375-20 |
| 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 | 2020-03-21 |