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

Model Number	PED2-425-20
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline's pushwire/ capture coil was stuck at the distal end of the phenom 27 catheter during retrieval.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery, in the sup erior hypophyseal with a max diameter of 3.03 mm and a 3 mm neck diameter.The landing zone was 3 mm distally and 4.18 mm proximally.It was noted the patient's vessel tortuosity was normal.The device looked good, the angiographic result was good post procedure.It was reported that the physician tried retrieving the delivery wire into the phenom 27 after deploying the device and could not retrieve the wire into the phenom 27.He needed to pull out the phenom 27 with the delivery wire at the same time.The catheter, pushwire, and capture coils were not damaged.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a microcatheter: phenom 27 lot # 231572698.
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.
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.
Event or Problem Description
Additional information was received.The cause of the event was not determined.There was no friction or difficulty during delivery or positioning; deployment was smooth with no issues.However, resistance was encountered at the distal end of the microcatheter in the m1 segment when retrieving the delivery wire.The catheter was flushed according to the ifu during the procedure.
Additional Manufacturer Narrative
Product analysis as found condition: the pushwire was returned stuck at the distal tip of the phenom 27 catheter, inside a bio-hazard bag, and a shipping box.The pipeline flex shield braid was 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 appeared to be stretched, but the ptfe shrink tubing remained intact.No defects were found in the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.An examination of the catheter tip and marker revealed no damage.The catheter body was accordioned from 4.0 cm to 7.4 cm from the distal tip.No other anomalies were noted.Testing/analysis: the pushwire was difficult to push out from the catheter lumen.The total and usable lengths were measured and found to be within specifications.The catheter was flushed with water and was found to be patent.An in-house 0.026¿ mandrel was then tested by running it through the catheter hub, successfully passing through without issues.However, the resistance was observed at the damaged locations.Conclusion: based on the returned devices, the customer complaint was confirmed, as the pushwire was found stuck at the distal tip of the phenom 27 catheter.The observed damage to the catheter (accordioning) and the hypotube (stretching) suggests that high force was probably applied.This damage may have occurred when the customer attempted to advance or retrieve the pipeline flex shield through the catheter against resistance.Possible causes of the resistance include vessel tortuosity and the lack of a continuous flush with heparinized saline during procedure.However, since the customer indicated that the vessel tortuosity was normal, it is ruled out as a potential cause.It is likely that the lack of continuous flush with heparinized saline contributed to the resistance encountered during retrieval.As the braid was not returned, its potential contribution to the resistance issue could not be assessed.Ls 2025-11-12.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: 23293364
• Report Number: 2029214-2025-02189
• Device Sequence Number: 14652079
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: (01)00763000284459(17)280409(10)D031973
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: D031973
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/11/2025; 11/13/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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: Female