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

Model Number PED2-450-18

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

Patient Problems Stroke/CVA (1770); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 07/05/2018

Event Type  Injury  

Event Description

Medtronic received report that a patient experienced a subacute infarct in the left frontal lobe after pipeline flex with shield implantation.The site reported that the event was likely the result of an ica dissection.The infarct was reportedly disease-related and not related to the device.Additional information received from the site indicated that the patient had a left middle cerebral artery stroke.The patient was hospitalized from (b)(6) 2018 to (b)(6) 2018.The ischemia in the left middle cerebral artery territory recovered/resolved on 24-jul-2018.A ct scan on (b)(6) 2018 showed sluggish flow through the left mca distribution without definite ischemic core ore penumbra and subacute infarct involving the left frontal lobe.An mri on 07-jul-2018 showed multifocal infarction and cerebral edema involving the left mca.The event lasted in new or worsening of existing neurological deficits that lasted for more than 24 hours.The site assessed the event as not related to the device and caused by the procedure.The patient was undergoing treatment for a saccular, side branch aneurysm located in the c5 segment of the left internal carotid artery.The max diameter was 13.4mm, the dome height was 10mm, the dome width was 13mm, and the neck size was 6.7mm.The patient artery diameter was 2.6mm distal to the aneurysm and 4.5mm proximal.Complete neck coverage and wall apposition were achieved in the procedure, and the post implant showed significant stasis in the aneurysm with an occlusion status of raymond and roy class 1.

Manufacturer Narrative

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

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: 14196999
• MDR Text Key: 293727570
• Report Number: 2029214-2022-00705
• 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,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/13/2022
• 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): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female