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 2020-03-18 for PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183930609]
However, since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183930610]
Interv neuroradiol. 2019 aug;25(4):407-413. Doi: 10. 1177/1591019918824003. Epub 2019 feb 25. ? Treatment of posterior inferior cerebellar artery aneurysms using flow-diverter stents: a single-center experience? Su? Kru? Og? Uz and hasan dinc. Medtronic received the following report through literature review: eight patients with eight aneurysms related to the pica were treated with a flow-diverter stent between september 2013 and may 2017. Half of the patients were female, and the mean age was 55 years (range, 34 to 71). Procedural success was 100% (8/8), and there were no ischemic complications. In two cases the proximal part of the stent shortened and migrated. Case #3: in one patient, we deployed a second stent telescopically. This patient presented with sah and was treated in the acute period but died because of rebleeding two weeks after the procedure (mrs, 6). Case #4: a (b)(6)-year-old male patient who had a right vertebral artery v4 segment incidental fusiform aneurysm. Digital subtraction angiography (dsa) image demonstrating a right vertebral artery v4 segment fusiform aneurysm involving the right posterior inferior cerebellar artery (pica) origin. The road-map image shows that the stent was dropped into the aneurysm sac, which passed near the stent. Fluoroscopic, dsa and dyna computed tomography images showing the final state; the second stent and the first stent were jailed in the aneurysm. (f) at the six-month follow-up dsa, the aneurysm was totally occluded, and the pica was patent. Four patients presented with sah, and three of them (case nos. 2, 3 and 8) developed impairment of consciousness secondary to acute hydrocephalus. Lumbar drainage was performed at regular intervals considering the changes in the patient? S state of consciousness. Hydrocephalus did not persist in the chronic period in any patient, and external ventricular drainage was not necessary. Other than case #3, all the patient mrs scores were zero at discharge and at the clinical follow-up period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00252 |
| MDR Report Key | 9848715 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-18 |
| 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 | MGR. 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 | 2020-03-18 |
| 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. Required No Informationntervention | 2020-03-18 |