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

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.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL 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 Key: 14164713
• MDR Text Key: 293721942
• Report Number: 2029214-2022-00679
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• 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 Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2022
• 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