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

Model Number PED2-300-14

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

Patient Problems Headache (1880); Muscle Weakness (1967); Dizziness (2194); Dysphasia (2195); Stenosis (2263); Obstruction/Occlusion (2422); Paresthesia (4421)

Event Date 04/26/2020

Event Type  Injury  

Event Description

Medtronic received a report that the patient experienced an acute infarction of the left anterior cerebral artery territory possibly related to the device and study procedure.The subject presented with right lower limb weakness, paresthesia, dysphasia, faint, and a slight headache, and was hospitalized from (b)(6) 2020 to (b)(6) 2020 and treated with medication and physical therapy.The patient fully recovered on (b)(6)2020 through physio, medications, and dsa neuro observation.The patient was undergoing surgery for treatment of a fusiform aneurysm in the left anterior communicating artery with a max diameter of 6.0mm and a 4.5mm neck diameter.One day post the procedure, the patient complained of a headache.Patient had occasional headache, described as a tight band around forehead, relieved with prn oxycodone, intensity was measured as 5/10 at worst, 2/10 with analgesia.The site adjudicated the event as ischemic stroke, possibly related to procedure and dapt, and casual relationship to device was reported.Additional information received reported that corelab imaging on the patient's 180-day follow-up visit on (b)(6) 2020 showed left a2 occlusion and parent artery stenosis of 25-50%.

Manufacturer Narrative

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

Event Description

Additional information received reported that the site denied the corelab comment of left a2 occlusion at the 180-day follow-up visit on (b)(6) 2020.It was stated that there was moderate in-stent stenosis with reduced flow in the left a2, but the a2 anterior communicating artery was not occluded.

Manufacturer Narrative

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 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: 12914234
• MDR Text Key: 284630907
• Report Number: 2029214-2021-01549
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: PED2-300-14
• Device Catalogue Number: PED2-300-14
• Device Lot Number: A745010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Date Device Manufactured: 11/27/2018
• 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): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female