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

Model Number	PED2-400-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Headache (1880); Vasoconstriction (2126); Ischemia Stroke (4418)
Date of Event	08/26/2024
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
Medtronic received information that a patient treated with a ped2 pipeline, navien58 catheter, and phenom27 catheter right internal carotid artery ascending cervical segment vasospasm. intraarterial verapamil 10 mg was administered.No hospitalization.The event resolved on (b)(6) 2024.The event had a causal relationship with the procedure. on (b)(6) 2024 office visit: continuation of bruising plavix is causing.Baseline aneurysm characteristics: side (hemisphere): right.Segment of  internal carotid artery (ica): c6.Location of aneurysm in vessel: sidewall.Aneurysm morphology: saccular.Maximum aneurysm diameter: 4mm.Aneurysm dome height: 4mm.Aneurysm dome width: 4mm.Aneurysm neck size: 4mm.Parent artery diameter distal to aneurysm: 3mm.Parent artery diameter proximal to aneurysm: 3mm.Additional information received reported intra-arterial verapamil 10mg was administered during the procedure to address the vasospasm.Site assessment determined the vasospasm had a causal relationship to the procedure.Navien and phenom catheter identifying information was not available.2025-feb-22 lsh 1308220934 (hcp, sdy): additional information received reported post procedure mri (b)(6) 2025 indicates multiple punctate recent infarcts within the right cerebral hemisphere, likely related to angiography.
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 sponsor assessed the vasospasm as caused by the procedure.It was reported that the patient experienced headache and bruising on 26-sep-2024.
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 excess bruising after using plavix.Investigator assessed the event as related to plavix.No change in medication was made.

• 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: 21635486
• Report Number: 2029214-2025-00698
• Device Sequence Number: 9372164
• Product Code: OUT
• UDI-Device Identifier: 00763000284336
• UDI-Public: 00763000284336
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2025

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: PED2-400-14
• Device Catalogue Number: PED2-400-14
• Device Lot Number: B727475
• 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: 02/22/2025
• Supplement Date Received by Manufacturer: 05/10/2025; 06/13/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/18/2025
• Date Device Manufactured: 05/03/2024
• 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: Other
• Patient Sex: Female
• Patient Weight: 62 KG