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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 Hemorrhage/Bleeding (1888); Ischemia (1942); Transient Ischemic Attack (2109); Rupture (2208); Stenosis (2263)
Event Date 04/29/2021
Event Type  Injury  
Event Description
Kang, h. , luo, b. , liu, j. , zhang, h. , li, t. , song, d. , zhao, y. , guan, s. , maimaitili, a. , wang, y. , feng, w. , wang, y. , wan, j. , mao, g. , shi, h. , zhang, y. , <(>&<)>amp; yang, x. (2021). Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications. Journal of neurointerventional surgery. Https://doi. Org/10. 1136/neurintsurg-2021-017445 summary: although coiling with a flow diverter may provide immediate dome protection, no studies have evaluated the effect on complications of postoperative occlusion degree immediately postoperatively. The purpose of this study was to determine whether postoperative occlusion degree immediately after flow-diverter placement with adjunctive coiling was associated with complications identified events: 1. 51 patients experienced major ischemic stroke. 44 patients were early post-operative and 7 patients were during the follow up period. 2. 34 patients experienced tia/minor stroke. 30 patients were early post-operative and 4 were during the follow up period. 3. 24 patients had dar (delayed aneurysmal rupture. 23 patients were early-operative and 1 was during the follow up period. 4. 23 patients had diph (distal intraparenchymal hemorrhage) during early-operative. 5. 114 patients had parent artery stenosis. 54 patients were early-operative and 60 were during the follow up period. 6. 120 patients had mrs deterioratoin. 85 patients were during early post-operative and 35 were during the follow up period. See attached literature article.
 
Manufacturer Narrative
Kang, h. , luo, b. , liu, j. , zhang, h. , li, t. , song, d. , zhao, y. , guan, s. , maimaitili, a. , wang, y. , feng, w. , wang, y. , wan, j. , mao, g. , shi, h. , zhang, y. , <(>&<)>amp; yang, x. (2021). Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications. Journal of neurointerventional surgery. Https://doi. Org/10. 1136/neurintsurg-2021-017445. 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 that the article was accepted for publication as the event dates were not provided in the published literature. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13596687
MDR Text Key286496394
Report Number2029214-2022-00302
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,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
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
Date Manufacturer Received01/28/2022
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: 02/24/2022 Patient Sequence Number: 1
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