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

Model Number	PED3-021-275-20
Medical Device Problem Codes	Retraction Problem (1536); Device Damaged by Another Device (2915); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a ped3 pipeline vantage migrated and another ped3 pipeline, phenom 21 catheter, and apro 55 catheter had resistance.Vantage 275x20 was placed through an existing vantage 275x16 due to the original device placed 5 days earlier slipping into the aneurysm and loosing its distal purchase.Upon deploying the device in a position satisfactory to the provider, the phenom 21 was advanced through the vantage to recapture the pusher wire and tip coils.The phenom 21 was advanced just past the distal marker and wouldn't advance further.The healthcare provider (hcp) attempted to retract the tip coil into the phenom 21 and felt significant resistance.The apro 55 was advanced further distally toward the phenom 21 tip and resistance was also felt.Another attempt was made to advance the phenom 21 with resistance not allowing it to advance over the tip coil.Another attempt was made to retract the tip coil into the phenom with significant resistance.The hcp applied more force to retract the tip coil and it retracted and was removed from the patient's body.The hcp did an angio and extravasation was observed at distal to the tip of the phenom 21 and proximal to the end of the tip coil.There was vessel perforation.Protamine was given and the hcp deployed two coils to stop the bleeding and case ended.The pushwire/capture coil stuck during retraction.The pushwire was rotated after removal.The pushwire was stuck to the distal tip of the phenom 21.The pushwire was damaged.The capture coil was damaged.There was severe friction during pipeline retrieval.The pipeline remains implanted in patient.The devices were prepared according to the instructions for use (ifu).  the patient wsa being treated for an unruptured, saccular aneurysm in the m2 location.The max diameter was 4mm and the neck diameter was 4mm.The distal landing zone was 7mm and the proximal landing zone was 8mm.Vessel tortuosity was severe.The access vessel was the left femoral.
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
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 that the doctor thought the original vantage may have migrated because the distal braid of the pipeline landed too close to the neck of the aneurysm and didn¿t have enough purchase to stay in position.There was no damage to the pipeline or pusher wire used for the original case done on (b)(6) 2024.

• Brand Name: PIPELINE VANTAGE WITH 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: 20585138
• Report Number: 2029214-2024-02051
• Device Sequence Number: 8827817
• Product Code: OUT
• UDI-Device Identifier: 00847536036321
• UDI-Public: 00847536036321
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PED3-021-275-20
• Device Catalogue Number: PED3-021-275-20
• Device Lot Number: B737225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 05/24/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male