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

Model Number	PED2-500-35
Medical Device Problem Codes	Unintended Ejection (1234); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
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
It was reported that during a neurovascular flow diversion procedure for a patient with a c7, c6, and c4 segment tandem aneurysm, a pipeline embolization device (ped2-5-30) could not be opened smoothly.The procedure involved placing the device from the distal end of m1 to the c3 segment.The first stent, ped2 4.5-30, was successfully deployed without issues.However, the second stent, ped2-5-30, failed to open properly despite being retrieved twice.Upon withdrawal from the body, it was found to have dislodged into p27 (phenom 27 microcatheter).The stent was then replaced with a ped2 4.75-35, which was successfully deployed, completing the operation.The aneurysm was unruptured, saccular in morphology, with a maximum diameter of 7.2mm and a neck diameter of 15mm.The landing zone artery sizes were 4.77mm distally and 3.2mm proximally, with normal vessel tortuosity.Angiographic results post-procedure were normal.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
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 received reported that the pipeline had been deployed in the phenom 27 microcatheter.The pushwire was not rotated or pulled back during deployment.The distal of the pipeline could not be opened.The pipeline was not placed in a vessel bend when it failed to open.No additional operations were attempted to open the device.The cause of the event could not be determined.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-78210), ruler (m-83361) as found condition: the pipeline flex shield braid and phenom 27 catheter were returned for analysis within shipping box; within a plastic bio-pouch; and within a dispenser coil.The pipeline flex pushwire was not returned for analysis.Therefore, any contributing factors could not be assessed.Damage location details: the braid was returned stuck within catheter hub.The distal end of pipeline flex shield braid was found to be not opened due to damaged braid.The proximal end of pipeline flex shield braid was found to be fully opened and damaged.No flash or voids molded were observed in the hub.No bent or kink was found with catheter body.No damage was found with catheter tip and 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 cut to remove the braid from catheter hub.The catheter was flushed with water and water exited out from the distal tip.Conclusion: based on the analysis findings, the pipeline flex shield was confirmed to have failure/incomplete open at distal as the distal end of pipeline flex shield braid was found to be not opened due to damaged braid.However, the cause for damage could not be determined.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: 20835147
• Report Number: 2029214-2024-02230
• Device Sequence Number: 8628004
• Product Code: OUT
• UDI-Device Identifier: 00763000284756
• UDI-Public: 00763000284756
• 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): 02/19/2025

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: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B699737
• 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: 12/01/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 02/05/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/02/2025; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 Age: 68 YR
• Patient Sex: Female