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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Numbness (2415)
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Caterina michelozzi, jean darcourt, adrien guenego, anne-christine januel, philippe tall, matthias gawlitza, fabrice bonneville, and christophe cognard. Flow diversion treatment of complex bifurcation aneurysms beyond the circle of willis: complications, aneurysm sac occlusion, reabsorption, recurrence, and jailed branch modification at follow-up. Journal of neurosurgery 131 (2019). Doi: 10. 3 171/2018. 7. Jns18654. The purpose of this study is to present the authors¿ medium-term results, with special emphasis on complications, occlusion rate of the aneurysm sac (digital subtraction angiography [dsa] and mri), and the fate of cortical branches and perforating arteries covered (¿jailed¿) by the flow diverter (fd) stent. Reported events. A patient was undergoing treatment of an aneurysm located at the right middle cerebral artery with a neck/dome size of 5. 8/12. 2mm. The patient presented with subarachnoid hemorrhage (sah), staged treatment with incomplete coiling 6 months earlier. The patient had a delayed complication of a silent perforator stroke after 9 months. A patient was undergoing treatment of two aneurysms located at the right middle cerebral artery with a neck/dome size of 3. 3/5. 4mm and 4. 0/6. 9mm. The patient was asymptomatic upon presentation. The patient had a delayed complication of minimal sulcal hemorrhage of unknown origin. A patient was undergoing treatment of an aneurysm located at the left middle cerebral artery with a neck/dome size of 5. 0/18mm. The patient presented with subarachnoid hemorrhage (sah), staged treatment with incomplete coiling 10 months earlier. The patient had delayed complication of a perforator stroke after 17 days. The patient experienced hemihypesthesia, and it was completely reversible after 24 hours. A patient was undergoing treatment of an aneurysm located at the right middle cerebral artery with a dome size of 14mm. The patient presented with subarachnoid hemorrhage (sah), staged treatment with incomplete coiling 7 months earlier. The patient had a periprocedural complication of sulcal sah probably due to wire tip perforation of a distal mca branch, with contrast medium collection on systematic post procedure cone beam ct. A patient was undergoing treatment of an aneurysm located at the anterior communicating artery complex with a neck/dome size of 5. 2/8. 0mm. The patient was asymptomatic upon presentation. The patient had a delayed complication of a silent heubner's perforator stroke after 4 months. A patient was undergoing treatment of an aneurysm located at the left middle cerebral artery with a neck/dome size of 5. 0/10. 0mm. The patient presented with subarachnoid hemorrhage (sah) treated by coiling 3 years earlier, now aneurysm recurrence. The patient had a delayed complication of a silent perforator stroke after 4 months.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10899727
MDR Text Key218224239
Report Number2029214-2020-01185
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-REP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2020 Patient Sequence Number: 1
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