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

Model Number	PED2-475-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
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 failed to open distally.The patient was undergoing surgery for treatment of a saccular, unruptured, left carotid artery aneurysm with a max diameter of 5 mm and a 4 mm neck diameter.The landing zone was 4.2 mm distally and 4.5 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered at an unknown platelet reactivity units (pru) level.The angiographic result post procedure showed an intracranial aneurysm.It was reported that the patient had a left internal carotid artery aneurysm.The operator selected a pipeline shield dense-mesh stent.After the access was successfully established, the stent was delivered to the ipsilateral m1 segment.After approximately 7¿8 mm of the distal tip end of the stent was exposed, a waiting period of about 10 seconds was observed; however, the distal tip end failed to open.The stent was then further deployed by approximately 12 mm, but the distal tip end still did not open.The operator attempted resheathing and redeployment.Despite maneuvers such as shaking, pushing, and pulling, the distal tip end remained unopened.Additional attempts, including adjustment of microcatheter tension, were unsuccessful.The stent was subsequently withdrawn from the body, and it was confirmed that the distal tip end could not open.A replacement stent was used, and the procedure was completed successfully.There were no patient symptoms or complications associated with this event.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).Ancillary devices include a silver snake guide catheter and a phenom 27 microcatheter.
Additional Manufacturer Narrative
H6: coding update based on additional information.H3: product analysis as found condition: the pipeline flex w/ shield device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an opened pipeline flex w/ shield inner pouch.The phenom-27 micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the pipeline flex w/ shield hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damage was found with the resheathing marker, re-sheathing pad or with the proximal bumper.The distal delivery wire was found kinked near the dps sleeves.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found slightly damaged.The braid was not returned for analysis.Testing/analysis: n/a conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the braid was not returned for analysis.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.Customer reported all devices were prepared per ifu and patient vessel tortuosity as moderate.The likely cause could not be determined.As the phenom-27 micro catheter used in the event was not returned for analysis, any contribution of the phenom-27 micro catheter to the failure could not be determined.The phenom-27 micro catheter is compatible for use with the pipeline flex w/ shield.There is no indication that the event is related to a potential manufacturing issue.The distal wire was found kinked and the tip coil was found slightly damaged.It is possible the damages occurred due to the same cause of the failure to open.It is a lso possible the damage occurred during handling/return to medtronic for analysis as the device was returned without its protective introducer sheath and dispenser coil.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: 24606170
• Report Number: 2029214-2026-00440
• Device Sequence Number: 10372046
• Product Code: OUT
• UDI-Device Identifier: 00763000449469
• UDI-Public: (01)00763000449469(17)280825(10)D060517
• 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,Followup,Followup
• Report Date (Section B): 06/18/2026

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: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: D060517
• 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: 03/14/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/18/2026; 06/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/13/2026; 06/15/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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 Age: 62 YR
• Patient Sex: Male