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

Model Number	PED2-475-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding 2 pipeline flex with shield devices that failed to open at the distal end.The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular ophthalmic artery segment aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 3mm.Vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered; pru level was 25.It was reported that the pipeline devices and all accessory devices were prepared as indicated in the instructions for use (ifu). while attempting to deploy both pipelines the distal end would not open.The first pipeline (model: ped2-450-12, lot: b311431) was resheathed 3 times and on the third time resheathing, the pipeline became stuck in the middle of the phenom microcatheter.It was considered that the pipeline may have come off the resheathing pad.The second pipeline (model: ped2-475-12, lot: b316802) also failed to open at the distal end and was resheathed 2 times without opening successfully.It was noted that more than 50% of the pipeline was deployed when it failed to open.No additional steps or devices were tried to open the pipelines.The pipeline was not positioned in a vessel bend.The physician released the slack in the system but it did not resolve the issue.There was no damage noted to the catheter or the pipeline pushwires.Continuous catheter flush was administered during the procedure.The second pipeline was replaced with a pipeline of another size which was used and deployed successfully.There was no harm or injury to the patient.Post-procedure angiography showed "very good" results.
Additional Manufacturer Narrative
This event is associated with event reported in rr#: 2029214-2022-00608.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
• Common Device Name: 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: 14075929
• Report Number: 2029214-2022-00609
• Device Sequence Number: 14096211
• Product Code: OUT
• UDI-Device Identifier: 00763000284596
• UDI-Public: 00763000284596
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2024
• Device Model Number: PED2-475-12
• Device Catalogue Number: PED2-475-12
• Device Lot Number: B316802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/11/2022
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female