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.
[183973076]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183973077]
Mahajan a, banga v, chatterjee a, goel g. Endovascular rescue strategies for nonopening of pipeline device: report of two cases.? Asian journal of neurosurgery. 2019;14(4):1240. Http://search. Ebscohost. Com/login. Aspx? Direct=true&db=edb&xsan=139871667&site=eds-live. Accessed march 17, 2020. Medtronic received a report through literature regarding two patients who underwent endovascular rescue strategies due to non-opening of the pipeline device. The first patient was a (b)(6)-year-old female. During the progressive deployment of pipeline, there was nonopening at its proximal end. Multiple attempts were made to open the device but the issue did not resolve. The patient continued to have raised blood pressure and bradycardia. Despite aggressive medication their pupils became dilated and fixed, with them also having persistent severe vasospasm of distal vessels. The patient died on day 2 postprocedure. The second patient was a (b)(6)-year-old female. During the progressive deployment of device, there was nonopening of the mid and proximal segment of pipeline flex which was successfully managed by intra-navien deployment of device followed by simultaneous push of marksman microcatheter and pull of navien catheter. Two rescue strategies were applied to successfully open the proximal constricted portion of pipeline flex. Vessel wall apposition of pipeline flex device was well achieved, and no balloon angioplasty was done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00248 |
| MDR Report Key | 9845811 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| 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 |