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

Model Number	PED3-021-300-14
Medical Device Problem Codes	Collapse (1099); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Speech Disorder (4415); Ischemia Stroke (4418)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
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 physician placed a vantage on (b)(6) 2025 in the a1-a2 of the patient's right side to cover a previously clipped acom that had recurred.The patient returned on (b)(6) 2025 with a right side stroke in the a2 segment.Angio confirmed the distal portion of the device had shut down.The physician was able to successfully open the a2 segment with aspiration and an atlas stent.The physician confirmed that the patient did miss their dose of dapt following discharge from the hospital.The patient was undergoing surgery for treatment of a saccular, unruptured acom aneurysm with a max diameter of 1mm and a 1mm neck diameter.Landing zone: distal: 2.5mm and proximal: 2.2mm.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed that the physician was able to successfully open the a2 segment with an atlas stent.The pipeline was used for an indication that is not approved (off-label).It was used in the a1-a2 segment on the patient's left sid e.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There were patient symptoms or complications associated with this event.It was noted that the patient received a pipeline vantage on (b)(6) 2025 from right a1-a2 to cover a previously clipped acom that had recurrence.The patient returned to the hospital on (b)(6) 2025 with a stroke in the right a2.Ancillary devices include a bmx81 sheath, sofia 5f guide catheter, phenom 21 microcatheter, and aristotle 18 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.
Event or Problem Description
Additional information received reported the patient had a stroke on her right a2, the physician is still not sure how she will recover.They are hoping for minimal deficits to her motors or speech.The physicians both worked to open the stent with a zoom 35 aspiration catheter.This was the only catheter small enough to fit into the vessel.After getting a small recan of the a2 with the zoom 35, they put an atlas stent in to hopefully keep the vessel open.The physician believes the cause of the pipeline shutting down was due to the patient stopping her dapt immediately following discharge from the hospital.
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 VANTAGE WITH 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: 22046858
• Report Number: 2029214-2025-01216
• Device Sequence Number: 8908222
• Product Code: OUT
• UDI-Device Identifier: 00847536036352
• UDI-Public: (01)00847536036352(17)270808(10)B771477
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED3-021-300-14
• Device Catalogue Number: PED3-021-300-14
• Device Lot Number: B771477
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 08/17/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/12/2025; 08/17/2025
• Date Device Manufactured: 08/08/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1246-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female