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

Model Number	PED3-027-400-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263); Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
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 no actions were taken to resolve the occlusion and stroke.
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 information that two ped3 pipeline vantages were occluded.The giant internal carotid artery (ica) cavernous aneurysm was treated with pipeline vantage.On follow-up it was discovered that the stent was completely occluded.Patient was asymptomatic.The healthcare provider (hcp) felt that the flow dynamic change and small stenosis within the ica segment caused this.Felt comfortable treating the pica origin aneurysm following this.2 tetra coils were implanted at the dome of the aneurysm preserving pica and a pipeline vantage was placed across pica in the vertebral artery.Patient returned to hospital with stroke-like symptoms.It was found that the vantage was completely occluded.It is unknown at this time what follow up testing/imaging was done to determine this.Both stents were reported to be completely occluded.1st implant in ica was asymptomatic; 2nd stent in vert was symptomatic and caused a small pica stroke to the patient.The devices were prepared according to the instructions for use (ifu).The second pipeline as used in an indication that was not approved.It was used in the posterior circulation; vertebral artery.The patient was being treated for an aneurysm in the giant ica cavernous; vert/pica origin.Giant cavernous was amorphous/ pica was saccular.Open stent with full wall apposition both proximal and distal.No post processing needed on either stent.Vessel tortuosity was normal.Ancillary devices: phenom plus (ica)/apro 55(vert).Phenom 27 microcatheter, synchro 14 select, stryker tetra coils in pica.

• 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: 19799813
• Report Number: 2029214-2024-01287
• Device Sequence Number: 7525655
• Product Code: OUT
• UDI-Device Identifier: 00847536036727
• UDI-Public: 00847536036727
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/29/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: PED3-027-400-20
• Device Catalogue Number: PED3-027-400-20
• Device Lot Number: B692381
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/29/2024
• Date Device Manufactured: 02/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female