MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-325-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Visual Impairment (2138); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the patient had stenosis or thrombosis in the side branch vessels or parent arteries covered by the flow divider.In addition the patient had diplopia, left abducent nerve paralysis.The adverse event was not considered to be severe.The event was resolved on (b)(6) 2022.It was indicated antiplatelet therapy was utilized.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left vertebral artery (va) with a max dia meter of 8.0mm and a 2.7mm neck diameter.Additional information was received indicating the lesion site was the left vertebral artery.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 13890409
• MDR Text Key: 287842645
• Report Number: 2029214-2022-00471
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: PED2-325-20
• Device Catalogue Number: PED2-325-20
• Device Lot Number: B189531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/24/2022
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female