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	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm dense mesh stent implantation procedure for a side wall aneurysm of the c6 ophthalmic artery segment, a pipeline embolization device was used.The aneurysm was unruptured, saccular, with a diameter of 5mm and a neck diameter of 4.7mm.Landing zone: distal: 4.2 mm and proximal: 4.5 mm.The accessed vessel was the femoral artery with a diameter of 7 mm.The procedure was complicated by severe vessel tortuosity.During the deployment of the stent at the m1 straight segment, the distal end of the pipeline stent could not be opened well and remained umbrella-shaped.Despite waiting and attempting retrieval and redeployment, the issue persisted.It was suspected that the distal end of the stent might have been damaged.The surgeon then attempted to open the stent at the distal end of c7, but the problem continued.Consequently, the decision was made to switch to a different stent model, ped2-5-30, which was successfully deployed according to the standard procedure, and the surgery was completed without further complications.Angiographic results post-procedure were reported as normal.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id fg15150-0615-1s (lot: 228687105); product type: ; 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
Additional information received that the cause of the failure to open/damage was not determined.The pipeline had not been placed in a vessel bend when it failed to open.There were no additional steps or other devices attempted to open the pipeline.
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 braid was returned inside a biohazard bag and a shipping box.Visual inspection/damage location details: the distal end of the braid appeared not opened and frayed.The proximal end of the braid was 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 confirmed as the distal end of the braid was not opened and frayed.The cause of failure to open could not be determined.Possible causes include severe vessel tortuosity, damaged braid, and the user deploying the braid in a vessel bend.However, the customer reported that the braid was not positioned in a vessel bend, which rules this out as a potential cause.In this event, the severe vessel tortuosity and 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: 20746682
• Report Number: 2029214-2024-02173
• Device Sequence Number: 12856396
• 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
• Device Explanted 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): 02/05/2025

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: B699523
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: Not provided; 01/31/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/18/2024; 02/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown