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

Model Number UNKNOWN

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

Patient Problems Hematoma (1884); Hemorrhage, Subarachnoid (1893); Paresis (1998); Perforation of Vessels (2135)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

Citation: virtual simulation with sim size software for pipeline flex embolization: evaluation of the technical and clinical impact lorenzo piergallini ,1,2 federico cagnazzo et.Al.The pipeline flex devices will not be returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through literature review.In our experience, the use of the virtual simulation during pipeline treatment significantly reduced the need for corrective intervention, the procedural time, the radiation dose, and the length of the stent.In the univariate analysis, compared with interventions without sim size use, procedures with the software had a lower rate of need for corrective intervention (9% vs 20%, p=0.036).Overall, in the group without simulation, five patients (5%) experienced complications: one small intraparenchymal hematoma due to a perforator artery rupture, likely caused by the guidewire of the stent; two minor strokes (diffusion-positive spot in the lenticular and corona radiata, respectively) with light motor symptoms completely regressed; one modest subarachnoid hemorrhageafter procedure likely due to the arterial stretching; and one small intraparenchymal hematoma together with modest subarachnoid hemorrhage, likely due to perforator artery rupture.In the group with simulation, three patients (3%)experienced complications: one embolic partial occlusion of the right central sulcus (rolandic) artery with hemiparesis that partially resolved; one minor stroke with a transient deficit of the leg; and one asymptomatic internal carotid artery dissection.All complications but one (the embolic central artery partial occlusion in the simulation group, in which leg weakness persisted after discharge) fully resolved without sequelae.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9929148
• MDR Text Key: 189090537
• Report Number: 2029214-2020-00338
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No
• 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