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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 Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Riitta rautio, melissa rahi, ari katila and jaakko rinne. Single-center experience with six-month follow-up of fred jrvr flow diverters for intracranial aneurysms in small arteries. Acta radiologica 0 (2018). Doi: 10. 1177/0284185118805266 abstract background: the flow-diverter stent (fd) has been proven to be a safe and efficient device in the treatment of large and giant wide-necked proximal internal carotid artery aneurysms. Purpose: to report the outcomes using flow re-direction endoluminal device junior (fred jr) flow diverters in the treatment of aneurysms in or distal to the circle of willis with parent artery diameter<(><<)>2. 5 mm. Material and methods: all electively treated aneurysms with this fd at our institution between september 2015 and december 2016 were retrospectively reviewed. Technical issues, immediate and follow-up radiological findings, and clinical outcomes were assessed. Fifteen patients with 15 aneurysms were included in the study. Results: no technical difficulties or complications were encountered during the fd procedure. No fd-related postprocedural complications or mortality occurred. The patients were discharged with unaltered national institute of health stroke scale (nihss) or modified ranking scale (mrs). Complete occlusion was reached in 13/15 aneurysms (87%) as assessed from the most recent radiological follow-up (6¿24 months). Conclusion: our preliminary results show that the device worked technically well with no complications for aneurysms located on small intracranial arteries. The occlusion rates are comparable to those of other fds that have been used in small arteries. The device offers a good choice in treating aneurysms that are unmanageable with conventional endovascular techniques or surgery. Reported event: - a 47 year old male was previously treated with a pipeline embolization device for a middle cerebral artery aneurysm; however, the initial stent position had changed distally so that it was no longer covering the aneurysm neck.

 
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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 Key10341150
MDR Text Key206962860
Report Number2029214-2020-00747
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeFI
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 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device LOT NumberUNKNOWN
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 Received07/21/2020
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: 07/29/2020 Patient Sequence Number: 1
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