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

Model Number	PED2-475-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 231549531); product type; implant date n/a; explant date n/a; product id ped2-500-20 (d047574); product type: implant date; explant date.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 there was failure to open of the pipeline devices.The patient was undergoing surgery for aneurysm flow-diverting stent implantation procedure as treatment of a fusiform, unruptured right c6 segment aneurysm with a max diameter of 3.2 mm and a 4 mm neck diameter.The landing zone was 3.6 mm distally and 4.9 mm proximally.It was noted the patient's vessel tortuosity was severe.The access vessel was the femoral artery with a vessel diameter of 5.6 mm.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was normal.The angiographic result post procedure was right c6 segment aneurysm.Since the target lesion was a right c6 aneurysm, under neuro guidewire guidance, the phenom 27 microcatheter was advanced along the guidewire and placed toward the distal vessels of the m2 segment of the middle cerebral artery.After the phenom 27 microcatheter was positioned in the middle cerebral artery, the operator advanced the flow-diverting stent ped2-500-20 to the middle cerebral artery and began deployment.At that time, it was noted that approximately two-thirds of the ped2-500-20 stent had already been deployed, and the tip end of the flow-diverting stent failed to open.The operator attempted to retrieve the flow-diverting stent ped2-500-20 and reposition it for redeployment; however, during withdrawal of the phenom 27 microcatheter, the ped2-500-20 stent still failed to open.Despite multiple attempts with flow-diverting stent ped2-500-20, the issue could not be resolved.The operator observed that the ped2-500-20 stent could not be opened, and repeated retrieval attempts revealed a fish-mouth¿like deformation at the tip end of the flow-diverting stent ped2-500-20.The operator then used the phenom 27 microcatheter to retrieve the flow-diverting stent ped2-500-20 into the microcatheter, at which point the phenom 27 microcatheter was also found to be no longer usable.Therefore, a new ph enom 27 microcatheter and a new flow-diverting stent ped2-475-18 were used instead.Under neuro guidewire guidance, the phenom 27 microcatheter was advanced to the middle cerebral artery for positioning, and the ped2-475-18 flow-diverting stent was deployed.During withdrawal of the phenom 27 microcatheter, it was observed that the tip end of the flow-diverting stent ped2-475-18 still failed to open.After several attempts, the flow-diverting stent still could not be opened.As described above, despite multiple attempts by the operator, the stent failed to open and the issue could not be resolved.At this point, the operator decided to recover the flow-diverting stent ped2-475-18 and replace it with a new flow-diverting stent ped2-475-25.The phenom 27 microcatheter was again advanced to the middle cerebral artery for positioning, and the flow-diverting stent ped2-475-25 was deployed.At this point, the flow-diverting stent ped2-475-25 was successfully opened, and the procedure was completed successfully.Angiography performed by the operator showed that the tip end of the flow-diverting stent ped2-475-25 was fully opened with good wall apposition, and the procedure was completed successfully.The catheter was flushed as indicated in the ifu.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 pipeline was used for an approved (on-label) indication.
Additional Manufacturer Narrative
Product analysis ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; and within primary and secondary plastic bio-pouch.¿damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found fully opened and damaged.No other anomalies were observed.¿ testing/analysis: n/a ¿ conclusion: based on the device analysis and reported information, the customer report of ¿failure/incomplete open distal¿ was not confirmed as the device was resheated.In addition, the proximal and distal ends could not be identified.The pipeline flex braid was found fully opened.However, the root cause for damage could not be determined.Possible causes of ¿failure/incomplete open¿ include vessel tortuosity, damaged braid, and deployment of the braid in the vessel bend.However, the customer indicated that the braid was not positioned in the vessel bend, which eliminates this factor out as potential causes.In this event, the damaged braid may have contributed to the failure to open.The braid can become damaged due to resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.Howev er, the cause of the braid damage could not be determined.It was noted the patient's vessel tortuosity was severe.It is likely that the severe vessel tortuosity may have contributed to the reported issue 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.The report that the phenom 27 microcatheter was no longer usable means that the stent could not be retrieved into the phenom microcatheter and became stuck.No causes or contributing factors for the event were identified.The pipeline was not placed in a vessel bend when it failed to open.Repeated attempts were made to open the pipeline by retrieving and redeploying the device.
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: 24484687
• Report Number: 2029214-2026-00329
• Device Sequence Number: 10684949
• Product Code: OUT
• 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: 2026
• Device Explanted Year: 2026
• 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): 05/05/2026

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: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: D053779
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 04/17/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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.; SEE H11...
• Patient Age: 65 YR
• Patient Sex: Male