MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	UNK-NV-FG13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Paresis (1998); Stenosis (2263); Obstruction/Occlusion (2422); Hydrocephalus (3272); Ruptured Aneurysm (4436); Aneurysm expansion (4597)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic literature review found a report of aneurysm rupture with subarachnoid hemorrhage and hydrocephalus requiring ventriculoperitoneal shunt placement, transient hemiparesis, in-stent stenosis, in-stent occlusion, and residual aneurysm in association with pipeline embolization.The timeline of this study was from january 2021 to may 2025.The purpose of this article was to evaluate the safety and efficacy of the pipeline vantage flow diverter for cerebral aneurysm treatment in small parent vessels =2.5 mm.The authors reviewed 14 cases of patients treated for a cerebral aneurysm using pipeline vantage flow diverter.Of the 14 patients, the average age was 68 years, 11 were female and 3 were male.The article states two patients had 2 stents placed due to suboptimal positioning of the first stent over the aneurysm neck.These patients also had adjunctive balloon angioplasty performed to improve apposition.In addition, the mrs scores at the latest follow up are as follows: 10 patients had a mrs score of 0, 3 patients had a mrs score of 1 and 1 patient had a mrs score of 4.The following intra- or post-procedural outcomes were noted: acute aneurysm rupture with grade 4 subarachnoid hemorrhage with hydrocephalus requiring ventriculoperitoneal shunt placement in 1 p atient one patient experienced transient hemiparesis within 24 hours of stent insertion which fully resolved within a few hours given bolus dose of abciximab in-stent stenosis found in 2 patients asymptomatic in-stent occlusion in 1 patient residual aneurysm in 5 patients.
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
B5 updated with additional information received.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 the adverse events described in the article did not relate directly to the medtronic devices.

• Brand Name: PHENOM CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24738028
• Report Number: 2029214-2026-00568
• Device Sequence Number: 9840322
• Product Code: QJP
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: UNK-NV-FG13
• Device Catalogue Number: UNK-NV-FG13
• Device Lot Number: UNKNOWN
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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; Life Threatening
• Patient Sex: Unknown