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

Model Number	PED2-500-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
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 the patient was undergoing treatment for a saccular, unruptured left internal carotid artery aneurysm with a max diameter of 4 mm and a 3 mm neck diameter.It was noted that the patient's vessel tortuosity was moderate.The landing zone was 5mm distally and 4.5mm proximally.The access vessel was a femoral artery, with 6mm diameter.Dual antiplatelet treatment (dapt) was administered.The pru level was unknown. it was reported that during the procedure the surgeon encountered an issue; that the tip of the first pipeline ped stent couldn't be opened.It was replaced with a second stent, which still failed to open.During the procedure, attempts such as pushing, pulling, and retrieval were made, but the stents still could not be opened. after replaced it with a third stent, the procedure was completed. the exact cause of the stent open failure remained unclear.The angiographic result post procedure was intracranial aneurysm.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.
Event or Problem Description
Additional information was received.The cause of the reported failure to open was not determined.The distal section of the pipeline did not open.The device had not been placed in a vessel bend at the time of the event.Multiple attempts, including retrieval, pushing, and pulling, were made to open the pipeline but were unsuccessful.No resistance was encountered; however, the stent¿s tip end failed to open.A continuous saline flush was administered and maintained in accordance with the ifu.No damage was observed to the pipeline pushwire or catheter.There were no allegations made against 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
H3.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿as found condition: the pipeline flex shield embolization device was returned for analysis within shipping box; within a plastic bio-pouch; and within an opened pipeline flex shield inner pouch.Damage location details: no bent or kink was found with pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.The braid was returned already detached from the pusher; therefore, the proximal and distal ends could not be identified.The pipeline flex shield braid ends were found to be fully opened and damaged.No other anomalies were observed.Conclusion based on the analysis findings, the pipeline flex shield could not be confirmed to have failure /incomplete open at distal as the device was resheathed.In addition, the pipeline flex shield braid ends were found fully opened and damaged.However, the root cause for damage could not be determined.Possible causes of failure/incomplete to open include vessel tortuosity and damage braid.H6.Coding updated based on analysis findings.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: 22647071
• Report Number: 2029214-2025-01715
• Device Sequence Number: 8677758
• Product Code: OUT
• UDI-Device Identifier: 00763000284725
• UDI-Public: (01)00763000284725(17)270423(10)B722564
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 10/03/2025

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: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B722564
• 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: 07/27/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 09/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 62 YR
• Patient Sex: Male