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

Model Number	PED2-450-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular flow diversion procedure to treat six unruptured, saccular aneurysms at the ophthalmic artery segment on the left side, the ped2-450-25 stent tip failed to open fully during both the first and second deployment attempts.The aneurysms had a maximum diameter of 4.35 millimeters and a neck diameter of 4.11 millimeters, with a distal landing zone artery size of 3.58 millimeters and a proximal size of 4.53 millimeters.The vessel tortuosity was described as moderate.Dual antiplatelet treatment was administered, and the angiographic result post-procedure was normal.The stent was removed from the body and replaced with a new ped2 stent, successfully completing the operation.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that the cause of the failure to open was not determined.The pipeline had not been placed in a vessel bend when it failed to open.There were additional steps or other devices attempted to open the pipeline, specifically, the physician retrieved the stent and raised the intermediate catheter.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis #(b)(4).Equipment used: video inspection system (m-78210), ruler 200cm (m-83361) as found condition: the pipeline flex shield embolization device was returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield braid was returned attached to pushwire.Damage location details: the pushwire was found to be bent at ~124.3cm and ~138.5 from proximal end.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The distal end of pipeline flex shield braid was found to be not opened due to damaged braid.The proximal end of pipeline flex shield braid was found to be fully opened and damaged.No other anomalies were observed.Conclusion: based on the analysis findings, the pipeline flex shield was confirmed to have failure/incomplete open at distal as the distal end of pipeline flex shield braid was not fully opened due to damaged braid.However, the root cause for damage could not be determined.Possible causes of failure/incomplete to open include vessel tortuosity and damage braid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20821695
• Report Number: 2029214-2024-02215
• Device Sequence Number: 7804589
• Product Code: OUT
• UDI-Device Identifier: 00763000284558
• UDI-Public: 00763000284558
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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 Model Number: PED2-450-25
• Device Catalogue Number: PED2-450-25
• Device Lot Number: B684895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 04/08/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/02/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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 Age: 68 YR
• Patient Sex: Male