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

Model Number	PED2-300-20
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the pushwire was returned inside the outer carton, bio-hazard bag, and shipping box.The pipeline flex shield braid and catheter were not returned.Damage location details: the distal and proximal dps restraints were intact.The dps sleeves showed no signs of damage and were found to be intact.The distal hypotube and ptfe shrink tubing were also intact, exhibiting no signs of elongation.No defects were found in the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.No other anomalies were noted.Testing/analysis: n/a.Conclusion: based on the returned devices, the customer complaint was not confirmed, as the pushwire was returned without the braid and catheter.No damage was found with the returned pushwire.Possible causes of the resistance include vessel tortuosity and the lack of a continuous flush with heparinized saline during the delivery procedure.However, since the customer indicated that the vessel tortuosity was moderate and a continuous flush was used, these were ruled out as potential causes.The root cause could not be determined.As the braid and catheter were not returned, their potential contribution to the resistance issue could not be assessed.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.
Event or Problem Description
Medtronic received a report that after the pipeline flex with shield technology stent was deployed, recapturing the distal tip with the sleeves was unusually difficult.It was noted that the pushwire/capture coil stuck during retraction in the location of the ptfe sleeves.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a ruptured, fusiform, right middle cerebral artery (mca) aneurysm with a max dia meter of 7 mm and a 7 mm neck diameter.The landing zone arterial diameter was 1.9 mm distally and 3.1 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was not administered.The angiographic result post p rocedure showed the implanted device looked fine; the case went very well.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was used for an indication that is not approved (right mca; off-label).The pushwire was rotated during removal.The pushwire and catheter were not damaged.The capture coil was not damaged during removal.The ancillary devices included a phenom 27 microcatheter.2025-oct-10 e1 (rep, hcp, for): additional information was received.There was no friction or difficulty during delivery; the case proceeded as expected.The catheter was flushed per ifu and placed on a drip line.The procedure was completed by deploying the device and, rather than recapturing the sleeves, removing the wire and catheter together.The cause of any resistance was not determined.
Additional Manufacturer Narrative
**** supplement was sent for correction h2- report source , unchecking the foreing box since this report is a us complaint.**** 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: 23756744
• Report Number: 2029214-2025-02569
• Device Sequence Number: 13141960
• Product Code: OUT
• UDI-Device Identifier: 00763000284008
• UDI-Public: (01)00763000284008(17)280413(10)D032667
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/21/2026

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: PED2-300-20
• Device Catalogue Number: PED2-300-20
• Device Lot Number: D032667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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
• Patient Sex: Male