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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK FLEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Rupture (2208); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Event Date 08/11/2021
Event Type  Injury  
Manufacturer Narrative
Feng, s. -w. , luo, c. -b. , lee, c. -h. , chang, f. -c. , <(>&<)> lin, c. -j. (2021). Flow-diverter stent to manage intracranial aneurysms: a single center experience. Journal of the chinese medical association, 85(3), 358¿363. Https://doi. Org/10. 1097/jcma. 0000000000000619. 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.
 
Event Description
Feng, s. -w. , luo, c. -b. , lee, c. -h. , chang, f. -c. , <(>&<)> lin, c. -j. (2021). Flow-diverter stent to manage intracranial aneurysms: a single center experience. Journal of the chinese medical association, 85(3), 358¿363. Https://doi. Org/10. 1097/jcma. 0000000000000619 summary: endovascular coil embolization is an important method for managing intracranial aneurysms. However, aneurysm coiling may fail or be insufficient in geographically difficult aneurysms. A flow-diverter stent (fds) is an alternative in these difficult coiling aneurysms. Thus, this study reports the experience and outcome of fds management of intracranial aneurysms. Identified events: 1. 3 patients had in-stent thrombosis that was solved by percutaneous balloon angioplasty to improve the fds apposition. 2. 2 patients had distal embolization that was solved by percutaneous balloon angioplasty to improve the fds apposition. 3. 1 of the patient's had an iatrogenic direct carotid-cavernous fistula because of the perforation of cavernous ica by the guidewire. Consequently, the patient underwent tranvenous coiling with fistula cure. 4. 1 patient had an aneurysm rupture. 5. 1 patient had a permanent procedure-related morbidity.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key14164713
MDR Text Key293721942
Report Number2029214-2022-00679
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTW
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2022
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: 04/20/2022 Patient Sequence Number: 1
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