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

Model Number	PED2-425-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Vasoconstriction (2126); Dysphasia (2195)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that a patient treated with a ped2 pipeline, navien58 catheter, and phenom27 catheter had complicatio ns.Status post placement of the 7- french shuttle sheath in the right internal carotid artery shows significant catheter-associated vasospasm.Administered 10 mg of intraarterial verapamil over 10 minutes.No hospitalization.The event resolved on (b)(6) 2024.The event had a causal relationship with the procedure.The patient had bad headaches any time they change position.Baseline aneurysm characteristics: side (hemisphere): right.Segment of internal carotid artery (ica): c4.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 10.9mm.Aneurysm dome height: 11.9mm.Aneurysm dome width: 9.3mm.Aneurysm neck size: 6.4mm.Parent artery diameter distal to aneurysm: 3.5mm.Parent artery diameter proximal to aneurysm: 4.1mm.Additional information received that the actions/interventions taken to resolve the headache and vasospasm as previously stated was the administration of 10 mg of intra-arterial verapamil over 10 minutes.The cause of the headache and vasospasm were determined to be related to status post placement of the 7-french shuttle sheath in the right internal carotid artery shows significant catheter-associated vasospasm.Additional information received reported difficult singing and more changes in their voice.No hospitalization r surgical intervention was reported.The patient was recovering/resolving.The site reported an increase of mrs score with subject complaining of voice changes at 6 months.The site confirmed that the subject was intubated.
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 source stated the patient was noted to have acid reflux by an ent provider which was a new diagnosis.They were concerned that the clopidogrel could be causing the acid reflux.
Event or Problem Description
Additional information was received.Diagnostic tests were performed.It was clarified that the adverse event occurred in the post-procedure period.
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 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: 21686605
• Report Number: 2029214-2025-00761
• Device Sequence Number: 9234441
• Product Code: OUT
• UDI-Device Identifier: 00763000284459
• UDI-Public: 00763000284459
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: B668270
• 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: 03/08/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 11/10/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/07/2025; 12/05/2025
• Date Device Manufactured: 12/12/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female
• Patient Weight: 65 KG