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

Model Number	PED2-475-35
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the pipeline flex device and phenom 27 catheter were returned within a shipping box and a plastic bio-pouch.The pipeline flex device was returned within the phenom 27 catheter.Visual inspection/damage location details: the pipeline flex pusher was found extending out from within the phenom 27 catheter hub for ~50.0cm.No damage was found with the phenom 27 catheter hub, catheter body, or distal tip.The pipeline flex device was found resheathed within the phenom 27 catheter distal tip.No bends, kinks or stretching was found with the pipeline flex pusher distal hypotube.No damage was found with the pipeline flex pusher sleeves or tip coil.The pipeline flex braid proximal and distal ends were found open, but damaged (frayed).Testing/analysis: the pipeline flex device was pushed out from within the phenom 27 catheter without issue.During deployment, the pipeline flex pusher detached at the distal hypotube weld (solder joint).Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter resistance/stuck during delivery¿ and ¿difficulty navigation¿ reports could not be confirmed.Possible causes of ¿catheter resistance/stuck during delivery¿ include use of an incompatible catheter, patient vessel tortuosity, catheter damage, delivery system damage, insufficient catheter flushing or lack of continuous flush, or flush rate too low.Possible causes of ¿difficulty navigation¿ include incompatible devices, patient vessel tortuosity, damage to guidewire, catheter damage, or lack of continuous flush during delivery.In this event, it is likely the patient's moderate/strong vessel tortuosity contributed to the reported event.However, the cause 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
Medtronic received a report that the parent blood flow of the aneurysm was disrupted and there was a large axial deviation, so it took approximately 40 minutes to reach the distal part of the aneurysm.At first, phenom 27 was used, but as it was not possible to reach the distal part, it was replaced with sl-10 and reached the target.After phenom 27/the relevant product reached the distal part of the aneurysm, an event occurred when an attempt was made to remove and deploy the sleeve in the middle part of the middle cerebral artery.When the surgeon used wire pushing to bring out half of the distal coil, commented that they felt a resistance stronger than anything had ever experienced before.The tip coil was stored in the phenom 27 once, and the system was tried to push again, but the resistance did not change.Despite an attempt to push the wire quite strongly, the tip coil would not advance, and as it seemed unsafe to continue the procedure, the phenom 27 and the relevant product were removed.The surgeon commented that there was a problem with phenom 27 or the product.Distal part aneurysms were removed again using another lot of phenom 27, synchro select standard, and another lot of pipelines of the same size was placed.Due to insufficient proximal landing zone, ped2-475-25 was placed and the procedure was completed.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the package insert.The catheter was wetted as per the package insert.The pipeline was used for an approved (on-label indication).Additional information was received clarifying the report that "it took about 40 minutes to reach the distal end of the aneurysm." stating that this was unexpected.Originally, it was scheduled to reach the distal end in 2.3 minutes.There was no resistance during delivery.The stent did not come out at all.After removal from the body, when it was pushed quite hard, the stent came out.There were no issues with the replacement phenom and pipeline, and there was a comment saying that it was quite smooth.The patient was undergoing flow diverter surgery for treatment of a spindle-shaped, unruptured right c2 to c4 (fischer classification) aneurysm with a max diameter of 25 mm and a 15 mm neck diameter.The landing zone was 3.7mm distal and 4.6mm proximal.Was noted the patient's vessel tortuosity was moderate/strong.The access vessel was the internal carotid artery with a diameter of 3.7~4.65mm.Dual antiplatelet therapy (dapt) was administered.Postoperative findings related to blood flow contrast were no problems; contrast agent accumulates in the aneurysm.Ancillary devices include a sl10 straight microcatheter, synchro select standard (0000803772), ped2-475-35 (lot: b593984), ped2-475-25 (lot: b426490), intermediate catheter phenom plus (fg19120-1030-1s lot: 230834552) additional information received reported resistance occurred around the tip of the catheter.Continuous saline flush was administered and maintained as indicated in the instructions for use (ifu).

• 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: 22967818
• Report Number: 2029214-2025-01966
• Device Sequence Number: 18426322
• Product Code: OUT
• UDI-Device Identifier: 00763000284664
• UDI-Public: (01)00763000284664(17)261008(10)B636950
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: PED2-475-35
• Device Catalogue Number: PED2-475-35
• Device Lot Number: B636950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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 Sex: Female