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

Model Number	PED2-425-20
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient had a c7 segment aneurysm with tortuous vessel conditions.The operator placed a phenom 27 stent at m2 and a 6f navien stent at c4.After the stent was fully hydrated, it was delivered.The plan was to open the stent tip at m1, however, the tip end of the stent was opened about 5-8mm at m1, but the tip end of the stent was still not opened.Healthcare provider (hcp) pushed the stent and increased the tension, but the tip end of the stent was still not opened.The stent was withdrawn by about 2-3mm.After waiting for about 10 seconds, the stent still did not open, the operator retrieved the microcatheter.After retrieval, the stent was deployed by about 3mm, and tension was increased to deploy it.However, the stent tip still did not open.The operator withdrew the stent entirely to the terminal portion of the internal carotid artery and continued to increase tension for deployment.The stent tip still did not open.The operator then retrieved the microcatheter and attempted in-situ deployment at the pre-planned anchoring location.The stent tip still could not fully open and adhere to the vessel wall.After several unsuccessful attempts, the surgeon observed rough texture of the fibrous tissue at the tip of the stent under fluoroscopy.In order to reduce the damage to blood vessels and ensure the safety of surgical patient, the operator withdrew the stent from the patient's body, and the tip of the stent was rough with naked eyes.After the stent was replaced, it was deployed in situ, the stent was successfully opened and the surgery was successfully completed.The pipeline was used for an indication that is approved (on-label).The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient is alive with no injury.The patient was undergoing surgery for treatment of a saccular, unruptured left posterior communicating artery segment aneurysm with a max diameter of 7 mm and a 4 mm neck diameter.The landing zone was 3.1mm distally and 4.4mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was normal situation.The angiographic result post procedure was smooth blood vessels.Ancillary devices include a intermediate catheter 6f 115 navien, phenom27 (fg15150-0615-1s) microcatheter, 0.014-inch synchro guidewire.
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
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 there was no damage to the blood vessels caused by the medtronic device.The cause of the event was not determined.The pipeline had not been placed in a vessel bend when it failed to open.There were no additional steps or other devices attempted to open the pipeline.
Additional Manufacturer Narrative
H3: product analysis of (b)(4), lotno:b781813 ¿ as found condition: the pipeline flex shield braid was returned inside the outer carton, biohazard bag, and a shipping box.¿ visual inspection/damage location details: the distal and proximal ends of the braid were opened and frayed.No other anomalies were observed.¿ conclusion: based on the returned device, the customer's report of failure to open at the distal end was not confirmed, as the distal end of the braid was opened and frayed.The cause of the failure to open could not be determined.Possible causes include vessel tortuosity, damaged braid, or deploying the braid in a vessel bend.The braid can become damaged due to over-manipulation, improper deployment technique, delivering/retracting the delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause of the braid damage 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.

• 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: 23441647
• Report Number: 2029214-2025-02312
• Device Sequence Number: 14642202
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: (01)00763000284459(17)270830(10)B781813
• 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: 2025
• Device Explanted Year: 2025
• 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): 01/07/2026

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: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: B781813
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 12/30/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/01/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG