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 2020-03-19 for PIPELINE NV UNK PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184174928]
See related regulatory report 2029214-2020-00261. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184174929]
Enriquez-marulanda a, salem mm, ascanio lc, et al. No differences in effectiveness and safety between pipeline embolization device and stent-assisted coiling for the treatment of communicating segment internal carotid artery aneurysms.? The neuroradiology journal. 2019;32(5):344-352. Doi:10. 1177/1971400919845368. The aim of this study is to analyze pipeline angiographic and functional outcomes, and procedural complications. The average age was 61 years old, 80. 1% female. 21 patients in total were implanted with a pipeline device. Complete occlusion was achieved in 71. 4% of the procedures, and there were three patients who required retreatment with an additional pipeline placement. A fourth patient also died 1 month after the second procedure due to a massive occipital hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00262 |
| MDR Report Key | 9856614 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| 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; 2. Other | 2020-03-19 |