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

Model Number	PED2-500-30
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 230602991); 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 information regarding a pipeline flex stent that failed to open at the distal end.The patient was undergoing a procedure for flow diverter treatment of a left internal carotid artery (l-ica) unruptured saccular aneurysm vial femoral access.The aneurysm max diameter was 9.38mm and the neck diameter was 5.97mm.The distal landing zone was 4.92mm; the proximal landing zone was 5.20mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered and pru level showed normal reaction level.It was reported that the devices were prepared and catheter was flushed per the instructions for use (ifu).The pipeline was delivered with the phenom 27 microcatheter.During deployment, the distal end of the pipeline stent did not open well despite multiple attempts.Push-pull, swinging, and retrieval/redeployment did not have any significant effect.As the patient's vessel had intimal damage from the multiple attempts, it was decided to replace the whole system due to also having concern for potential damage to the catheter.The pipeline was deformed.The microcatheter and pipeline were both replaced and the surgery was completed successfully.There were no other patient symptoms or complications associated with this event.
Event or Problem Description
Additional information was received.The cause of the pipeline failure to open was not determined.The pipeline had not been placed in a vessel bend when it failed to open, and it was not resheathed during the procedure.No visible damage was observed on the phenom 27 microcatheter.
Additional Manufacturer Narrative
Updated b5, d9 h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event.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
H3 product analysis: as found condition: the pipeline flex shield device was returned stuck inside the returned phenom 27 catheter, inside the sealed biohazard bag, and inside a shipping box.Damaged location details: the pipeline flex shield tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were intact, with no damage noted.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube was stretched.No kinks or bends were found on the pusher wire.The braid¿s distal and proximal ends were open and frayed, while the middle section was fully open without damage.The phenom 27 catheter tip and marker were examined, and no damage was noted.The catheter body was in good condition.No voids or flashes were found on the catheter hub.No other anomalies were found.Testing/analysis: the pipeline flex shield device was removed from the phenom 27 catheter lumen without difficulty.The phenom 27 catheter total and usable lengths were measured within specifications.The catheter was flushed with water and was found patent.The catheter was tested by running an in-house 0.026-inch mandrel through the hub and tip without issues.Conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ report could not be confirmed, as the returned pipeline flex shield braid¿s distal and proximal ends were open and frayed.However, the cause of the failure to open could not be determined.Possible causes of the failure to open include vessel tortuosity, the user deploying the braid in the vessel bend, and a damaged braid.In this event, the customer stated that the vessel tortuosity was moderate and that the pipeline had not been placed in a vessel, which rules out vessel tortuosity and the user deploying the braid in the vessel bend as possible causes.Therefore, a damaged braid could have contributed to the failure to open.The braid can be damaged by over-manipulation, deployment techniques, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing the delivery wire against resistance.However, the cause of the braid damage could not be determined.In addition, the damage noted on the braid (fraying) and distal hypotube (stretched) indicates that high force was used.The damage likely occurred when the customer attempted to advance the pipeline flex shield device through the phenom 27 catheter against resistance.Possible causes of resistance include a lack of continuous heparinized saline flush.However, the cause of resistance could not be determined.The customer¿s ¿catheter kink/damaged¿ report could not be confirmed because no damage was noted on the returned phenom 27 catheter.However, the cause of the event could not be determined.(b)(6).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
Correction to g3: date was missing in previous report.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: 23620836
• Report Number: 2029214-2025-02469
• Device Sequence Number: 21350367
• Product Code: OUT
• UDI-Device Identifier: 00763000449582
• UDI-Public: (01)00763000449582(17)280611(10)D045062
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2026

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: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: D045062
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 11/24/2025; Not provided; 01/13/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025; 01/28/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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: 59 YR
• Patient Sex: Female