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

Model Number	PED2-375-14
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after a flawless deployment of the pipeline flex with shield technology stent, the pipeline delivery system could not be retrieved through the phenom 27 microcatheter.There was too much tension trying to bring it in so the system was pulled out together as a unit without incident.It was noted that this has been encountered several times.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for dense mesh flow diversion treatment of a posterior communicating aneurysm.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices included a dude 0.082¿ intermediate catheter from radical medical.Additional information was received.The patient's vessel tortuosity was moderate.Resistance was encountered in the distal tip of the catheter.The delivery system and microcatheter were removed together as the pipeline pusher wire was not able to be pulled into the microcatheter.The cause of the resistance was not determined.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There was no damage observed to the pipeline pushwire or the catheter.The additional instances of this issue have been reported.
Additional Manufacturer Narrative
Continuation of d10: phenom 27 microcatheter model: fg15150-0615-1s, lot: 232031066.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 a continuous saline flush was administered and maintained as indicated in the ifu.There was moderate resistance during delivery.It was noted they went radial as well which may be less supportive.A bmx 81 catheter was used.There was no resistance in any section of the catheter other than the distal tip.
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.

• 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: 23596521
• Report Number: 2029214-2025-02447
• Device Sequence Number: 13090541
• Product Code: OUT
• UDI-Device Identifier: 00763000284244
• UDI-Public: (01)00763000284244(17)280428(10)D035760
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: PED2-375-14
• Device Catalogue Number: PED2-375-14
• Device Lot Number: D035760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 04/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 63 YR
• Patient Sex: Female