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

Model Number	PED2-500-18
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: fg15150-0615-1s (lot: 229627677); implant date: n/a; explant date: n/a.Product id: rfx058-115-08 (lot: b797699); implant date: n/a; explant date: n/a.Product id: ped2-500-18 (unknown).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
It was reported that during a neurovascular flow diversion procedure involving a pipeline flex device, the distal end of the device appeared crimped and would not open.The aneurysm was located in the left internal carotid artery at the ophthalmic artery, was unruptured, and had a saccular morphology.The aneurysm had a maximum diameter of 5 millimeters and a neck diameter of 4 millimeters.The distal landing zone was 4.1 millimeters, and the proximal landing zone was 5 millimeters, with normal vessel tortuosity.The physician attempted to deploy the device by unsheathing it in the m1 segment, but the distal end remained crimped and failed to open, although the mid portion did open.The device was resheathed and repositioned at the target location, but the distal end still did not open.This was the third device in a construct, and the decision was made to remove the device entirely.This was the second pipeline flex 5 x 18 device that was used.The first did the exact same thing.It was also removed and discarded.The pipeline was not placed in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient by resheathing and removing with the microcatheter.Dual antiplatelet treatment was administered with a platelet reactivity unit level of 98, and the angiographic result post-procedure was acceptable.The device was resheathed and removed with the microcatheter, and it was never implanted.  ancillary devices include: bmx96 guide catheter lot # h00005464 and aristotle 24 guidewire lot # 030518.
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 involving a pipeline flex device, the distal end of the device appeared crimped and would not open.The aneurysm was located in the left internal carotid artery at the ophthalmic artery, was unruptured, and had a saccular morphology.The aneurysm had a maximum diameter of 5 millimeters and a neck diameter of 4 millimeters.The distal landing zone was 4.1 millimeters, and the proximal landing zone was 5 millimeters, with normal vessel tortuosity.The physician attempted to deploy the device by unsheathing it in the m1 segment, but the distal end remained crimped and failed to open, although the mid portion did open.The device was resheathed and repositioned at the target location, but the distal end still did not open.This was the third device in a construct, and the decision was made to remove the device entirely.This was the second pipeline flex 5 x 18 device that was used.The first did the exact same thing.It was also removed and discarded.The pipeline was not placed in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.There were no additional steps or other devices required to open the pipeline.The pipeline was removed from the patient by resheathing and removing with the microcatheter.Dual antiplatelet treatment was administered with a platelet reactivity unit level of 98, and the angiographic result post-procedure was acceptable.The device was resheathed and removed with the microcatheter, and it was never implanted.Ancillary devices include: bmx96 guide catheter lot # h00005464 and aristotle 24 guidewire lot # 030518.
Event or Problem Description
Additional information received after the second 5x18 pipeline did not open, the physician removed the device and ended the case.The patient was left with one 4.25x25 and one 4.5x25 pipeline device.The cause of the failure to open was not determined.
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.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield device was returned for analysis inside a phenom 27 catheter, a sealed biohazard bag, and a shipping box.Damaged location details: the pipeline flex shield¿s tip coil is in good condition.The distal and proximal dps restraints and dps sleeves were found to be intact, with no signs of damage.No defects were found on the re-sheathing marker and re-sheathing pad.The distal hypotube and ptfe shrink tubing were intact, with no signs of elongation and damage.The braid¿s distal and proximal ends were opened and frayed, while the middle part was fully opened.No defects were found on the pushwire.No other anomalies were found.Testing/analysis: the pipeline flex shield pushwire was easily pushed from the catheter lumen.Conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ complaint was not confirmed, as the returned pipeline flex shield braid¿s distal and proximal ends were opened and frayed.The root cause of the failure to open could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, and damaged braid.In this event, the customer stated that normal vessel tortuosity was noted, and the device was not placed in the vessel bend, ruling out vessel tortuosity and the user deploying the braid in the vessel bend as potential causes.A damaged braid could have contributed to the failure to open.The braid can be damaged due to over-manipulation, deployment technique, delivering/retracting delivery wire against resistance, or deploying/re-sheathing 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: 21228866
• Report Number: 2029214-2025-00204
• Device Sequence Number: 12652165
• Product Code: OUT
• UDI-Device Identifier: 00763000284718
• UDI-Public: 00763000284718
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2025

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: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Device Lot Number: B721575
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided; 01/24/2025; 02/14/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/12/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 85 KG