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

Model Number	PED2-450-10
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
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 pushwire broke in the distal section.The patient was undergoing surgery for treatment of a saccular, unruptured terminus aneurysm with a max diameter of 3mm and a 2.5mm neck diameter.The landing zone was 3.0mm distally and 4.4mm proximally.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered and the pru level was 40.It was reported that the device was being resheathed through tortuous anatomy and the pushwire broke proximal to the resheathing pad.Since 90% of device was recaptured, once the doctor recognized the problem, the whole device was removed from the patient with the phenom 27 microcatheter.There was severe friction or difficulty during retrieval.A new device was inserted and successfully deployed.The angiographic result post procedure was normal.The pipeline was used for an indication that is approved (on-label).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 neuron max 088 sheath, navien 058 115cm guide catheter, and phenom 27 150cm microcatheter.
Event or Problem Description
Additional information received reported the pushwire break was during the first recapture of the device.Noticed the lead wire was only about halfway into the phenom 27 when the proximal markers were moving freely inside the more proximal segment of the 27.There was resistance trying to get the entire device and lead wire back into the 27.The pusher wire broke just proximal to the bumper.The physician felt resistance when re-sheathing the device.Continuous saline flush was administered and maintained as indicated in theinstructions for use (ifu).No damages were observed to the catheter.
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
Product analysis: as found condition: the pipeline flex shield embolization device and phenom 27 catheter were returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield was returned outside the phenom 27 catheter.The pipeline flex shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.Damage location details: the proximal section of the pipeline flex shield pushwire was not returned for analysis.Therefore, any c ontributing factors could not be assessed.However, the pipeline flex shield pushwire appeared to be detached at the hypotube proximal to the wire weld.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No flash or voids molded were observed in the hub.No damage was found with hub.The catheter body was found to be kinked at ~25.0cm from proximal end.No damage was found with the catheter distal tip/marker band.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out of the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged location.The ends of the detached pushwire were sent out for sem/eds analysis.Conclusion: based on the analysis findings, the pipeline flex shield was confirmed to have pushwire break/separation as the pushwire appeared to be detached at the hypotube proximal to the wire weld.Per the sem result ¿due to mechanical damage to the fracture surface, the mode of failure was unable to be determined¿.In addition, the pipeline flex shield and phenom 27 catheter were confirmed to have resistance during retrieval as the pipeline flex shield and phenom 27 catheter were found to be damaged.Possible causes include incompatible catheter, damaged catheter, burrs, bumps, kinks or other damage on ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, and users pulls back on/torques wire while advancing ped in microcatheter.From the damage seen on the catheter body (kinking), and pipeline flex shield pushwire(breaking); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the phenom 27 catheter against resistance.It is likely that severe vessel tortuosity may have contributed to the reported issues.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: 22170643
• Report Number: 2029214-2025-01340
• Device Sequence Number: 21177847
• Product Code: OUT
• UDI-Device Identifier: 00763000284497
• UDI-Public: (01)00763000284497(17)261030(10)B648141
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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: PED2-450-10
• Device Catalogue Number: PED2-450-10
• Device Lot Number: B648141
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 09/19/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/14/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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 Age: 82 YR
• Patient Sex: Female