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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 Problem Hydrocephalus (3272)
Event Date 12/01/2016
Event Type  Injury  
Manufacturer Narrative
Ye, z. , lv, x. The formation mechanism of acute dissection of blood blister-like aneurysm and its implication of endovascular treatment. Chinese neurosurgical journal (2021). Https://doi. Org/10. 1186/s41016-021-00245-1. This value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Refer to manufacturer report 2029214-2021-01072 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Ye, z. , lv, x. The formation mechanism of acute dissection of blood blister-like aneurysm and its implication of endovascular treatment. Chinese neurosurgical journal (2021). Https://doi. Org/10. 1186/s41016-021-00245-1. Medtronic literature review found reported of patient complications in association with the use of an echelon microcatheter in proximity to the intracranial aneurysm and deploy a stent (non-medtronic) across the entry point into the blood blister-like aneurysms (bbla) to the effect of jailing the preceding placed microcatheter. A few patients underwent successive sequential placement of a pipeline flow-diverting stent across the internal ostium of the bbla via a triaxial guiding catheter including a 6-fr intermediate navien catheter and a 0. 027-in. Marksman microcatheter and adjunctive coiling. ¿follow-up angiography conducted 3 to 8 months successive to treatment demonstrated complete aneurysmal obliteration in all patients. ¿ the purpose of this article was to develop a more intimate and nuanced understanding of the mechanisms underlying the pathogenesis of soi-disant bbla. 8 consecutive patients harboring bbla undergoing endovascular treatment of beijing tsinghua changgung hospital of tsinghua university were subjected to this retrospective review. Of the eight patients, the average age was 49 years, five were female. The following post-procedural outcomes were noted: re-bleeding successive to a closed-cell stent across the aneurysmal neck, non-occult hydrostatic hydrocephalus.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12373661
MDR Text Key268704148
Report Number2029214-2021-01073
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
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 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 Received08/03/2021
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: 08/26/2021 Patient Sequence Number: 1
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