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

Model Number NV UNK PIPELINE

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

Patient Problems Ischemia (1942); Muscle Weakness (1967); Obstruction/Occlusion (2422)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Cagnazzo f, fanti a, lefevre p-h, et al.Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature.Journal of neurointerventional surgery.2021;13(1):42-48.Doi:10.1136/neuri ntsurg-2020-015980.If information is provided in the future, a supplemental report will be issued.

Event Description

Cagnazzo f, fanti a, lefevre p-h, et al.Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature.Journal of neurointerventional surgery.2021;13(1):42-48.Doi:10.1136/neuri ntsurg-2020-015980 medtronic literature review found a report of patient complications in association with a pipeline device.The purpose of this article was to provide further insight into flow diversion for aneurysms located at, or distal to, the a2 segment.Twenty-three consecutive patients (12 women, 11 men; mean age, 61.5 years) with 25 distal anterior cerebral artery (daca)aneurysms were treated with flow diversion devices.Pipelines were used in the treatment of 18 of the aneurysms.The article does not state any technical issues during use of the pipeline device.Successful flow diverter deployment was obtained in all cases.The following intra- or post-procedural outcomes were noted: - one patient developed an acute occlusion of the calloso-marginal artery and frontopolar arteries covered with a pipeline.The stent had landed with lower porosity proximally compared with distally.This was mainly based on the following reasons.First, the larger proximal diameter of the parent artery (2.1¿1.8 mm) contributed to the lower porosity of the proximal segment of the stent.In addition, during stent deployment, due to the tortuous arterial anatomy, we filled a higher loading force on the microcatheter, causing a moderately higher degree of compaction of the proximal device.Thus, the lower porosity at the origin of the branching vessels was responsible for the acute slow flow of the covered arteries.Mean arterial blood pressure was increased up to 100 mmhg, however, the patient developed an ischemic lesion on the aca territory with a permanent deficit of the left foot dorsiflexion.The patient had left leg weakness and was monitored in the intensive care unit.

• Brand Name: PIPELINE
• 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: 13476935
• MDR Text Key: 286496151
• Report Number: 2029214-2022-00171
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2022

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 Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/07/2022
• 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): Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female