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

Model Number	PED2-500-20
Medical Device Problem Codes	Unintended Movement (3026); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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
Medtronic received a report that the pipeline tip failed to open and dislodged.The patient was undergoing surgery for treatment of an ophthalmic artery segment aneurysm with a max diameter of 5 mm and a 4 mm neck diameter.The landing zone was 4.9 mm distally and 5 mm proximally.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet therapy (dapt) was administered.The angiographic result post procedure was blood stagnation within the aneurysm.It was reported that after the stent microcatheter was positioned, ped2-500-20 stent was selected.Upon delivery to the target site, an attempt was made to deploy the pipeline stent; however, the tip failed to open.It was retrieved and a second deployment attempt was made, but it again failed to open.It was then retracted to the planned anchoring position, yet remained undeployable.Upon continuing the deployment attempt, the stent dislodged; consequently, the stent was withdrawn, replaced with a new one, and the procedure was successfully completed.The pipeline was not used for an indication that is not approved (off-label).The pipeline and accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.Ancillary devices include a ton-bridge medical 5f 115 guide catheter, a navien guide catheter, and a phenom 27 microcatheter.
Additional Manufacturer Narrative
H3 product analysis: document used: n/a.As found condition (condition of returned device): a pipeline flex embolization device was returned for analysis within a shipping box and within a sealed biohazard pouch.Visual inspection/damage location details: the pipeline pushwire was found to be bent at ~110.5cm and at ~113.4cm from proximal end.The hypotube was found to be stretched with ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves appeared to be in good condition.The tip coil was found to be damaged.Due to the condition in which the braid was returned the proximal and distal ends were unable to be determined.Braid end 1 was found to be opened and frayed.Braid end 2 was found to be opened and frayed.No other anomalies observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿movement during deployment¿ was unable to be confirmed.It is possible the cause for ¿movement during deployment¿ is due to poor braid placement and/or wall apposition.However, the root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as both braid ends were found to be open.Possible causes of failure include damaged braid, or user deploys braid in vessel bend.The root cause could not be determined.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 reported that the lesion was a saccular aneurysm of the right ophthalmic artery segment.The pipeline failed to open at the distal section and was not placed in a bend when it failed to open.Some additional steps taken in an attempt to open the pipeline were retrievement and redeployment.The tip end did not open sufficiently, resulting in inadequate anchoring was deemed a contributing factor for the movement/dislodgment.Multiple devices were not being used when the movement occurred.There was not any friction or difficulty during delivery or positioning during the process.The pipeline was not implanted at the intended location and jumped during the deployment.The catheter tip was withdrawn during deployment and any cause or contributing factors to the tip failure to open were not determined.

• 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: 24687491
• Report Number: 2029214-2026-00514
• Device Sequence Number: 10004180
• Product Code: OUT
• UDI-Device Identifier: 00763000449568
• UDI-Public: (01)00763000449568(17)281020(10)D074685
• 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: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/27/2026

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: D074685
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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: Unknown