MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-5-15-3D
Medical Device Problem Codes	Stretched (1601); Unintended Movement (3026)
Health Effect - Clinical Codes	Vasoconstriction (2126); Obstruction/Occlusion (2422); Ischemia Stroke (4418); Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Death
Event or Problem Description
Additional information was received stating that the patient passed away on (b)(6) 2025.Autopsy records are not available.Regarding the cause of death and any relevant medical events leading up to the patient's passing, it was noted that the patient had an underlying poor grade subarachnoid hemorrhage (wfns grade 5) with high likelihood of morbidity and mortality.The stretched coil which lead to complications of causing parent vessel occlusion and subsequent internal carotid artery (ica) territory infarction would have contributed to the poor outcome.It was confirmed that the coil protruded into the parent artery (a1 anterior cerebral artery segment, and internal carotid artery) during the procedure.Patient had intermediate tortuosity.The cause of the coil stretch was unknown.
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
It was reported that during a neurovascular procedure involving the axium qc coil, the device experienced coil stretch.It was reported that the coil was implanted, and the patient was "rip".It was unknown if there was any patient symptoms or complications associated with this event.Additional information received reported that it was confirmed the patient passed away.There cause of death was unknown at this time, though it was noted that there is no current evidence to suggest that the death was related to the medtronic device or therapy.The patient had underwent angiogram and coil embolization for a 7×5×4 mm irregular, lobulated, wide-necked anterior communicating artery (acomm) aneurysm (neck 3.5 mm), arising from left a1 aca segment.The coil stretch occurred during the procedure when attempting to remove a prominent coil loop protruding into the left a1/a2 junction.The stretched coil was ultimately removed using combined aspiration and a tigertriever xl and was not implanted.The coil stretch occurred due to repeated manipulation and traction during multiple retrieval attempts after balloon-assisted adjustment failed to resolve the prominent loop at the a1/a2 junction.The coil loop did protrude into the parent artery during the event.The device damage cause was related to mechanical stress during complex retrieval and device exchanges in the intra-procedural management of the coil loop.There were no additional post-procedure events or dose changes.It was noted there was mild vasospasm of the proximal a2 anterior cerebral artery (aca) segments bilaterally.There was minimal to normal vessel tortuosity.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22986603
• Report Number: 9617601-2025-01347
• Device Sequence Number: 15800589
• Product Code: KRD
• UDI-Device Identifier: 00847536037816
• UDI-Public: (01)00847536037816(17)270930(10)229753347
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: QC-5-15-3D
• Device Catalogue Number: QC-5-15-3D
• Device Lot Number: 229753347
• 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: 08/09/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 09/30/2024
• 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: Death
• Patient Sex: Unknown