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

Model Number	PED2-500-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
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 information regarding a pipeline flex with shield (ped2) stent that failed to open at the distal end.The patient was undergoing a procedure via femoral access for flow diversion treatment of a right internal carotid artery (r-ica) posterior communicating (pcom) segment unruptured amorphous aneurysm.The aneurysm max diameter was 6.54mm and the neck diameter was 5.1mm.The distal landing zone was 3.43mm and the proximal landing zone was 5.4mm.Vessel tortuosity was minimal.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).During deployment of the pipeline, the distal tip failed to open in the straight middle cerebral artery (mca) m1 segment.The microcatheter was withdrawn to deploy more than 1cm of the pipeline stent but it still could not be opened.The pipeline was resheathed and redeployed twice but still failed to open.The surgeon continued to wait and swung the stent slightly but it could not be opened.It was noted that the pipeline was not positioned in a bend.Finally, the pipeline was resheathed and removed with the microcatheter and replaced with a pipeline shield model: ped2-500-20 which was used smoothly to complete the procedure successfully.There was no harm or injury to the patient associated with this event.Post procedure angiography shows healthy and normal vascular patency and no bleeding or ischemic complications.Ancillary devices: phenom 27 microcatheter, 6f 90cm long sheath, bridge medical silver snake 6f 115cm intermediate catheter, 0.014in 200cm guidewire,.
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 there was no friction/resistance or other difficulties delivering the pipeline.Everything was normal.Ancillary devices: phenom27 lot 229010403.
Additional Manufacturer Narrative
H3: product analysis as found condition: the braid was returned inside of a biohazard bag and a shipping box.There was no pushwire returned with the braid.Visual inspection/damage location details: the braid's distal and proximal ends were found opened and frayed.No other anomalies were observed.Testing/analysis: n/a conclusion: based on the returned device, the customer report of failure to open at the distal end was not confirmed, as the braid's distal and proximal ends were found opened and frayed.The cause of failure to open could not be determined.Possible causes include vessel tortuosity, damaged braid, or deployment of the braid in a vessel bend.However, the customer reported that vessel tortuosity was minimal, and the braid was not positioned in a vessel bend, which rules these factors out as potential causes.In this event, the damaged braid may have contributed to the failure to open.The braid can become damaged due to resheathing more than 2 times, over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/resheathing the braid against resistance.However, the cause of the braid 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: 21878041
• Report Number: 2029214-2025-01038
• Device Sequence Number: 12729070
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: 00763000284732
• 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): 06/24/2025

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: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B671041
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/30/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/08/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 82 KG