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	12/18/2024
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 reporting that the failure of the device was determined to be a flaw of the product as per the physician.
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex shield device was returned for analysis inside a sealed biohazard bag and a shipping box.Damaged location details: the pipeline flex shield tip coil was in good condition.The distal and proximal dps restraints and dps sleeves were found intact, with no signs of damage.No defects were found on the re-sheathing marker or re-sheathing pad.The distal hypotube was found to be stretched.No damage was noted on the pushwire.The braid¿s distal end was not opened and frayed, while the proximal end was opened and frayed.The braid¿s middle part was fully opened.No other anomalies were found.Testing/analysis: n/a conclusion: based on the reported information and device analysis, the customer¿s ¿failure/incomplete to open at distal¿ complaint was confirmed, as the returned pipeline flex shield braid¿s distal end was not opened due to a damaged braid.The cause of the failure to open could not be determined.Possible causes include vessel tortuosity, the user deploying the braid in the vessel bend, or a damaged braid.The customer indicated that the vessel tortuosity was moderate, which ruled out the vessel tortuosity as a potential cause.It is possible that the user deploying the braid in the vessel bend and the damaged braid contributed to the failure to open.Damage to the braid can occur due to over-manipulation, deployment technique, advancing or retracting the delivery wire against resistance, or deploying/re-sheathing the braid against resistance.The observed damage on the braid (fraying) and hypotube (stretched) indicates that high force was likely used.This damage may have occurred when the customer attempted to advance or retrieve the pipeline flex shield device through the catheter against resistance.However, the root cause of the resistance could not be determined.One possible cause of the resistance could be a lack of continuous flush with heparinized saline during the procedure.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
Continuation of d10: product id: ped2-500-20 (b611120).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 procedure involving the pipeline embolization device, an unruptured saccular aneurysm was located in the right internal carotid artery.The device failed to open in the distal section twice, forming a "trumpet" shape during deployment.The device was positioned in a bend in the middle section, and more than 50% of the device had been deployed when it failed to open.The pipeline device was resheathed and removed with the microcatheter on both occasions.Dual antiplatelet treatment was administered with a platelet reactivity unit level of 240.The aneurysm had a maximum diameter of 8 millimeters and a neck diameter of 10 millimeters, with a distal landing zone artery size of 4 millimeters and a proximal size of 5 millimeters.The vessel tortuosity was moderate.Troubleshooting steps included the use of "wagging" techniques, which involved loading and offloading the combination of the microcatheter and delivery wire to attempt to open the device.After two attempts, the 5mm x 25mm pipeline flex shield device was removed, and a 5mm x 20mm flex shield device was used, but the same issue occurred.The decision was made to switch to a 5mm x 20mm pipeline vantage, which opened successfully, achieving technical success.The product was explanted.

• 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: 21107737
• Report Number: 2029214-2025-00094
• Device Sequence Number: 15440741
• Product Code: OUT
• UDI-Device Identifier: 00763000284732
• UDI-Public: 00763000284732
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/09/2025

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 Expiration Date: 01/09/2026
• Device Model Number: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B500546
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/21/2025; 03/13/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/13/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 75 YR
• Patient Sex: Female