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

Model Number PED-300-16

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

Patient Problems Apheresis (1719); Infarction, Cerebral (1771); Paresis (1998)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information through clinical study that post procedure patient experience right hemiparesis and aphasia has been assessed by site to have causal relationship to study procedure.The event was resolved on the same day.Additional information updated the event to a stroke.The patient underwent embolization treatment for a flow diversion of saccular left anterior cerebral artery bifurcation branch, measuring 13mmx9mmx13mm, neck 5mm, parent artery diameter distal 1.8mm, proximal 2.3mm.Post procedure complete stasis and class 2 occlusion.Next day of the procedure patient discharge home with self care.At six month follow up patient had class 1 aneurysm occlusion and 0-25% parent artery stenosis.Mrs score 0.No new events identified.History: occlusion of the left anterior choroidal artery due to the misplacement of a coil loop, the coil is not related to the target aneurysm.Severity moderate and the ae treated with a percutaneous intervention and concomitant or additional medication given.Per the information provided in the casebook, the subject had previous rupture on (b)(6) 2017.The date of past procedures and past treatment information is not collected in the study.

Manufacturer Narrative

Upon review of the event this was not a late submission as the provided information was not reportable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8843518
• MDR Text Key: 152710422
• Report Number: 2029214-2019-00796
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2018
• Device Model Number: PED-300-16
• Device Catalogue Number: PED-300-16
• Device Lot Number: A058829
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR