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 2020-03-17 for PIPELINE NV UNK PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183769836]
See related regulatory report 2029214-2020-00244. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183769837]
Lv x, jiang c, wu z, jiang w, wang g. Complex cerebral aneurysms: intra-luminal reconstruction using pipeline flow-diverting stent and the obliteration mechanism.? The neuroradiology journal. December 2019:1971400919894879. Doi:10. 1177/1971400919894879. Medtronic received a report through literature to document the clinical and angiographic outcomes in 80 patients who were treated with the pipeline flow-diverting stent. Forty-five patients were women and 35 were men, with a mean age of 52 years. The study took place between october 2015 and october 2019, 80 patients with 90 complex blood blister? Like, and recurrent side-wall cerebral aneurysms treated with the pipeline were reviewed. Forty-one aneurysms were large or giant, 41 were small, four were recurrent side-wall aneurysms, and four were blood blister? Like aneurysms. In seven patients, a second pfs was necessary to cover the aneurysm neck. Among them, coils were placed in addition to the pfs in 31 aneurysms. 82 of 83 aneurysms were occluded for a total occlusion rate of 98. 8% there was no patient related morbidity. Mortality occurred in one patient due to thrombolysis from thrombus formation in the left ica, resulting in an ipsilateral remote intraparenchymal hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00245 |
| MDR Report Key | 9843461 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-17 |
| 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 | PIPELINE |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2020-03-17 |
| 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 | 2020-03-17 |