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

Model Number	PED2-400-16
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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
Additional information was received that the cause of the resistance and delivery system break was unable to be determined.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): equipment used: video inspection system (m-78210), ruler 200cm (m-83361).As found condition: the pipeline flex shield pushwire was returned for analysis within a shipping box; and within a plastic bio-pouch.The pipeline flex shield braid was not returned for analysis.Therefore, any contributing factors could not be assessed.Damage location details: no bent or kink was found with pushwire.However, the pushwire was found to be separated/broken proximal to the dps sleeves.The distal hypotube was found to be stretched.The shrink tubing was found intact but pulled back from the proximal bumper.No damages were found with pads.The tip coil and dps sleeves were not returned for analysis and the reason was not provided.No other anomalies were observed.Testing/analysis: the broken end was sent out for sem (scanning electron microscopy) analysis.Conclusion: based on the analysis findings, the pipeline flex shield was confirmed to have resistance and pushwire break/separation as the pushwire was found to be broken and stretched.Per the sem result, the broken end failed via torsional overload.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
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 the delivery system was broken.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 5mm and a 4mm neck diameter.The landing zone was 3.6mm distally and 4.0mm proximally.It was noted the patient's vessel tortuosity was minimal.The angiographic result post procedure showed good adhesion to the wall, and the ped covered the aneurysm.It was reported that in the blood flow guided dense mesh stent implantation, after the normal deployment of the pipeline, when the s urgeon used phenom27 to retrieve the delivery system, the retrieval push rod was felt resistance, but the surgeon did not operate violently.When the delivery system was retrieved to phenom27, it was found from the imaging that the tip end of the delivery system was broken.The surgeon quickly removed the phenom27 and the delivery system as a whole from the body and found that the small wing and the distal end were broken and separated from the delivery system.Because the patient had already implanted with the pipeline and the broken tip end was not left in the human body, the patient was fine.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.

• 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: 19583961
• Report Number: 2029214-2024-01120
• Device Sequence Number: 7392737
• Product Code: OUT
• UDI-Device Identifier: 00763000284343
• UDI-Public: 00763000284343
• 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: 2024
• 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): 09/11/2024

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: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: B716497
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 09/11/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/18/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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
• Patient Sex: Unknown