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

Model Number	QC-2-4-3D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
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 a report that an axium coil encountered resistance and had prematurely detached.The patient was undergoing surgery for treatment of a gastrointestinal bleeding and interventional embolization.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the patient presented with upper gastrointestinal bleeding and underwent variceal embolization.During the microcatheter delivery of the spring coil, significant resistance and difficulty in advancing were encountered.Upon withdrawal, it was found that the spring coil had detached spontaneously.Another spring coil was then used to complete the embolization, and the procedure was successfully completed.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.
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 was received stating that the cause of the event was not determined.Resistance was noted in the middle section of the catheter.A continuous catheter flush was administered during the procedure.After removal, a kink was observed in the coil.The catheter used was not a medtronic product.
Additional Manufacturer Narrative
H3 product analysis: document used: n/a as found condition (condition of returned device): the axium device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: the axium device was returned within the introducer sheath, which was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.Both the actuator interface and the break indicator were found to be undamaged, with no evidence of any detachment attempts made at these locations.The pushwire was found to be bent at ~7.8cm, bent within the introducer sheath at ~155.6cm, bent at ~160.3cm and bent (damaged) outside of the distal end of the introducer sheath at ~164.2cm from the proximal end.The axium implant coil was found to be stretched and damaged; although still intact with the pushwire detach element; in addition, polypropylene filament was found to be intact with the pushwire.No other anomalies were observed.Testing/analysis (including sem reports): none.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the damaged found with the axium device was consistent with advancement against resistance.A few possible cause of catheter resistance are but not limited to, incompatible catheter, and damage or kink to pushwire; however, the root cause was unable to be determined.The catheter used in the procedure was noted to be a non-medtronic device and was not returned for assessment.The condition of the non-medtronic catheter, and any contribution the catheter had towards the damage/resistance was unable to be analyzed.Based on the device analysis and the reported information, the customer¿s report of ¿coil kink/damage¿ was able to be confirmed as the implant coil was returned damaged (stretched).The likely cause for the damage was determined to be advancement against the reported resistance.Based on the device analysis and the reported information, the customer¿s report of ¿premature detachment¿ was able to be unable to be confirmed, as the implant coil was found to be broken off and not returned for further assessment.The detach element was found to be intact with the pushwire subassemblies.A successful detachment was able to be produced during testing.The axium device was found to be compatible with both the echelon-10 microcatheter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was indicated that all devices were prepared as per the instructions for use (ifu); in addition, a continuous catheter flush was administered during the procedure.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: 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: 23996930
• Report Number: 9617601-2026-00136
• Device Sequence Number: 10398684
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: (01)00847536037625(17)270928(10)229753192
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 229753192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/12/2026; 02/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/13/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 71 KG