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

Model Number	PED2-250-20
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s ((b)(4)); implant date n/a; explant date n/a 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 report that the pipeline flex with shield stent failed to open at the tip during deployment.The pipeline then got stuck in the phenom 27 microcatheter during retrieval.It was noted that the devices were prepared and catheter flushed as indicated in the instructions for use (ifu).Both devices were replaced to continue the procedure.There was no harm or injury to the patient who was undergoing a procedure for flow diversion treatment of a middle cerebral artery (mca) m1 segment unruptured aneurysm.The aneurysm max diameter was 3mm and the aneurysm neck diameter was also 3mm.Vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered.Post procedure angiography showed the aneurysm with proximal aneurysm stenosis.
Event or Problem Description
Additional information received reported that the resistance was in the tip end of the catheter.There was no obvious damage observed to the pipeline pushwire or catheter.It was clarified that the distal end of the pipeline did not open.The pipeline had been placed in a vessel bend when it failed to open.In order to open they device they prepared to push it to go upper to the "intermediate tube", and it could not be opened smoothly at the intermediate tube.
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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 was found stuck inside the distal tip of the phenom 27 catheter, within the inner pouch, outer carton, bio-hazard bag, and shipping box.Damage location details: both the distal and proximal dps restraints were intact.The dps sleeves showed no signs of damage.The distal hypotube appeared to be stretched, but the ptfe shrink tubing remained intact.The braid's distal and proximal ends were found to be opened and frayed.The pushwire showed no bends, and there were no defects observed in the tip coil, distal marker, re-sheathing marker, resheathing pad, or proximal bumper.The catheter tip and marker were examined with no damages found.However, the catheter body was found to be accordioned from 6.4 cm to 17.6 cm from the distal tip.No other anomalies were observed.Testing/analysis: the pipeline flex shield could not be pushed forward or removed.The catheter was cut to remove the pipeline flex shield from the catheter lumen.The total and usable length were measured within specifications.The catheter was flushed with water and found to be patent.It was then tested by running an in-house 0.026" mandrel through the catheter hub without issue; however, resistance was observed at the damaged locations.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: 21919661
• Report Number: 2029214-2025-01084
• Device Sequence Number: 9073547
• Product Code: OUT
• UDI-Device Identifier: 00763000283889
• UDI-Public: 00763000283889
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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: PED2-250-20
• Device Catalogue Number: PED2-250-20
• Device Lot Number: B677869
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 05/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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: Female