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

Model Number	PED2-375-25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the pipeline flex pushwire was returned for analysis.The micro catheter used in this event was not returned for analysis.Therefore, any contributing factors could not be assessed.No bent or kink was found with pushwire.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.The pipeline flex shield pushwire was found to be detached at distal hypotube and the remaining distal segments were not returned for analysis.Therefore, any contributing factors could not be assessed.In addition, the pipeline flex shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.No other anomalies were observed.Based on the analysis findings, the pipeline flex shield was confirmed to have resistance as the pipeline flex shield pushwire was found to be damaged.In addition, the pipeline flex shield pushwire was found to be detached.From the damages seen on the hypotube (stretching) and pushwire detaching; it is likely high force used during the delivery.It is possible these damages occurred when the customer attempted to advance and retrieve the pipeline flex shield through the catheter against resistance.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
It was reported that after the doctor retrieved the pipeline once during the operation, encountered resistance with the phenom when pushing it again.Failed after another attempt, but succeeded after replacing the catheter and stent.The pipeline was used for an indication that is approved.The pipeline and any accessory devices were prepared as indicated in the ifu.There were no patient symptoms reported.The patient was being treated for a saccular, unruptured aneurysm in the communicating artery with a max diameter of 5mm and a neck diameter of 5mm.The landing zone was 10mm distally and 12mm proximally.Vessel tortuosity was minimal, angiographic result post procedure was good.Dapt (dual antiplatelet treatment) was administered.Additional information received reported the resistance was in the proximal end of the catheter.There was no damage to the pipeline pushwire or catheter observed.

• 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: 21319118
• Report Number: 2029214-2025-00303
• Device Sequence Number: 7915969
• Product Code: OUT
• UDI-Device Identifier: 00763000284282
• UDI-Public: 00763000284282
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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: PED2-375-25
• Device Catalogue Number: PED2-375-25
• Device Lot Number: B667502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: 56 YR
• Patient Sex: Male