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

Model Number	PED3-027-500-14
Medical Device Problem Codes	Structural Problem (2506); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Nervous System Injury (2689)
Date of Event	04/30/2024
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
Medtronic received a report that the device was placed correctly and physician was pleased, post placement.5 hours post procedure, patient exhibited stroke like symptoms, with weakness and physician brought the patient back into the ir lab.Imaging showed foreshortening on the proximal portion of the pipeline as well as fish-mouthing.The brain also appeared to pro-lapse into the an.There was migration after deployment with an unknown cause.The pipeline was implanted at the intended location and full wall apposition was achieved.A-choroidal side branch covered by the pipeline.The pipeline was used for an approved indication.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a bi-lobal, unruptured left distal internal carotid artery (ica), para a-choroidal  aneurysm with a max diameter of 5.87mm.The landing zone was 2.88mm distally and 2.5mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered.Ancillary devices include a bmx81 guide catheter, aristotle 18 guidewire.
Event or Problem Description
Additional information received reported the pipeline braid pro-lapsed into the aneurysm.The cause of the migration was not determined.The stroke-like symptoms were weakness in the left side of the body.An additional atlast stent was used to tack down the proximal portion of 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.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19249375
• Report Number: 2029214-2024-00861
• Device Sequence Number: 20442500
• Product Code: OUT
• UDI-Device Identifier: 00847536036895
• UDI-Public: 00847536036895
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/22/2024

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 Expiration Date: 04/05/2025
• Device Model Number: PED3-027-500-14
• Device Catalogue Number: PED3-027-500-14
• Device Lot Number: B675957
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/22/2024
• Date Device Manufactured: 02/20/2024
• 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: 42 YR
• Patient Sex: Female