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

Model Number	PED2-450-18
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during the treatment of a right c6 segment aneurysm, after opening the navien 072, phenom 27, and avigo, the phenom 27 was advanced to the lesion site.The dense mesh flow-diverting stent ped2-400-20, lot: d052881 was fully flushed before introduced into the phenom 27.It was then advanced into the phenom 27 and pushed to the target lesion, and deployment of the stent was initiated.During deployment, it was found that the tip could not be opened.The stent was withdrawn into the phenom 27, and an attempt was made to re-deploy by pushing the pusher rod, but it still failed to open.Multiple attempts of pushing, pulling, retrieving, and redeploying were unsuccessful.Subsequently, both the phenom 27 and the dense mesh flow-diverting stent were removed from the body.When attempting to push the dense mesh flow-diverting stent out of the phenom 27 outside the body, excessive resistance was noted.The device was then replaced with a ped2-450-20 dense mesh flow-diverting stent.Under guidewire navigation, the microcatheter was advanced to the distal m1 segment.After thorough hydration of the dense mesh flow-diverting stent, the protective sheath was advanced to the hub of the microcatheter, and the dense mesh flow-diverting stent was delivered.However, during deployment of the stent tip, the tip again failed to open.Even after releasing the stent to the proximal half, the distal portion remained un opened.Multiple attempts of pushing, pulling, retrieving, and redeploying were still unsuccessful.Fluoroscopy revealed damage to the tip of the stent.Considering procedural safety, the device was replaced again with a ped2-450-18 dense mesh flow-diverting stent.The above steps were repeated, and the stent was successfully deployed.As the wall apposition was suboptimal, a guidewire was used to massage, followed by post-dilation with a super-compliant occlusion balloon at the site of poor apposition.Final angiography confirmed satisfactory wall apposition of the stent, and the procedure was ended.The pipelines failed to open in the distal section.The pipelines were not positioned in a bend.More than 50% of the pipeline had been deployed when they failed to open.The pipelines were resheathed less than or equal to 2 times.No additional steps or other devices were required to open the pipelines.The pipelines were resheathed and removed from the patient with the microcatheter.The pipelines were used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a saccular, unruptured right c6 segment aneurysm with a max diameter of 3.2mm and a 2mm neck diameter.Landing zone: distal: 3.8mm and proximal: 4.1mm.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.Pru level was 1.The angiographic result post procedure showed treatment of aneurysm in the right c6 segment.Ancillary devices include a navien guide catheter, p27 microcatheter, avigo 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Update b5, d4 and h4 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.The cause of the failure to open was determined to be resistance, which occurred in the distal section of the catheter.A continuous saline flush was administered and maintained as indicated in the ifu.No damage, such as kinking, stretching, or separation, was observed on the pipeline pushwire or catheter.
Additional Manufacturer Narrative
Correction to h6: imf code f11 was corrected to f26.Fdd code a15 was missed and has now been included.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: 23805084
• Report Number: 2029214-2025-02634
• Device Sequence Number: 13108785
• Product Code: OUT
• UDI-Device Identifier: 00763000284534
• UDI-Public: (01)00763000284534(17)280907(10)D062848
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: D062848
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 12/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/16/2026
• Date Device Manufactured: 09/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 58 KG