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

Model Number	PED2-400-16
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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 a pipeline flex stent failed to open completely and was damaged during delivery/retrieval.The patient was undergoing flow diversion surgery for treatment of an unruptured, saccular aneurysm, at the c7 location, with a max diameter of 4.3 mm and a 1.8 mm neck diameter.The landing zone artery diameter was 2.78 mm distally and 3.8 mm proximally.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered.The angiographic result post procedure showed slowed blood flow.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).During the procedure, after the stent was in place, the tip end of the stent opened, but the middle part got kinked when it was deployed.After retrieval and other operations, it failed to open.The stent was removed and replaced with another medtronic stent to successfully complete the procedure.No patient symptoms or complications were associated with this event.
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 was received.During delivery of the pipeline device, friction and resistance were encountered.The middle section of the stent failed to open despite attempts at retrieving adjustment.The device was not deployed in a vessel bend at the time of the event.The failure was attributed to a slight kink in the stent.
Additional Manufacturer Narrative
H3: product analysis: as found condition: the pipeline flex device was returned within a shipping box and a plastic bio-pouch.Visual inspection/damage location details: no bends, kinks, or stretching was found with the pipeline flex pusher.The pusher resh eathing pad, sleeves, and tip coil were found to be in good condition.The braid was returned detached from the pusher; therefore, the proximal and distal ends could not be identified.Both ends of the braid were found partially open, but damaged (frayed).However, the middle section of the braid was found open and not kinked.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete to open at middle section (hourglass shape)¿, ¿pipeline damaged (middle)¿, and ¿resistance during delivery¿ reports could not be confirmed.The middle section of the returned pipeline flex braid was found open and not kinked.Possible causes of ¿resistance/stuck during delivery¿ include use of an incompatible catheter, catheter damage, patient vessel tortuosity, user does not maintain continuous flush, or users pulls back on/torques wire while advancing pipeline in microcatheter.Possible causes of ¿failure/incomplete to open at middle section (hourglass shape)¿ include patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.Possible causes of ¿pipeline damaged (middle)¿ include resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting the device against resistance.The catheter used in the event was not returned and the make/model was not provided.Therefore, any contributing factors (including incompatible catheter/catheter damage) could not be assessed.Information regarding if a continuous flush was maintained and number of resheathing attempts was not reported.It was noted that the patient's vessel tortuosity was minimal.The device was not deployed in a vessel bend at the time of the event.It is likely that the deployment of the device against resistance contributed to the damage found with the returned pipeline flex braid ends.However, the cause(s) of the reported resistance, failure to open, and damage (middle) could not be determined.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 stating that the catheter was not a medtronic device.

• 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: 22679436
• Report Number: 2029214-2025-01732
• Device Sequence Number: 8937524
• Product Code: OUT
• UDI-Device Identifier: 00763000284343
• UDI-Public: (01)00763000284343(17)271008(10)B800051
• 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): 09/29/2025

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: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: B800051
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/01/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male