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

Model Number	PED2-300-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
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 was received stating that the cause of the event was not determined.
Event or Problem Description
Medtronic received a report that a pipeline failed to open in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the left c6 segment.The aneurysm dimensions include a max diameter of 2.2mm, neck diameter of 2.4mm, landing zone or artery size of 2.7mm distal and 3.0mm proximal.It was noted the patient's vessel tortuosity was normal.It was asked but unknown if dapt (dual antiplatelet treatment) administered.The angiographic result post procedure was a new dense mesh stent was used instead.Contrast agent remained in the aneurysm, and vascular blood flow was unobstructed.It was reported that during intracranial artery embolization treatment, a dense mesh stent was delivered, but the distal end could not be opened during the opening process.Three attempts were made, but all failed.A new stent was used instead.In the distal section of the pipeline device failed to open.The pipeline device was not positioned in a bend.It was not specified if the pipeline was stuck in the capture coil.More than 50% of the pipeline device had been deployed when it failed to open.The pipeline was not used for an indication that is not approved (off-label).It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.
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
Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361) as found condition: the pipeline flex embolization device was returned for analysis within shipping box; and within a bio-pouch.Damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex braid ends were found to be fully opened and damaged.No other anomalies were observed.Conclusion: based on the analysis findings, the pipeline flex could not be confirmed to have failure/incomplete open distal (flex) as the device was resheathed.In addition, the proximal and distal ends could not be identified.The pipeline flex braid ends were found fully opened and damaged.However, the root cause could not be determined.Possible causes include patient vessel tortuosity, braid damaged, braid deployed in vessel bend.It was noted that the patient's vessel tortuosity was minimal.Which eliminate this factor out as potential causes.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
H11 product analysis correction: the second to last sentence of the conclusion was updated to: it was noted that the patient's vessel tortuosity was normal and the pipeline was not placed in a vessel bend.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: 24020393
• Report Number: 2029214-2026-00033
• Device Sequence Number: 21075310
• Product Code: OUT
• UDI-Device Identifier: 00763000448820
• UDI-Public: (01)00763000448820(17)280824(10)D060104
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 03/20/2026

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: PED2-300-16
• Device Catalogue Number: PED2-300-16
• Device Lot Number: D060104
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 01/12/2026; 02/23/2026; 03/08/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/14/2026; 03/09/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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