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

Model Number	QC-2-6-3D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during delivery of an axium coil it encountered resistance and detached automatically.The patient was undergoing treatment for interventional embolization surgery.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the patient had upper gastrointestinal bleeding and underwent variceal embolization.During the delivery of the coil with the microcatheter there was significant resistance making advancement difficult.Upon withdrawal, the coil detached automatically.Another coil was then used instead to complete the embolization.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 information was received stating that the cause of the event was not determined.The catheter used was not a medtronic product.Resistance was encountered in the middle section of the catheter.A continuous catheter flush was administered during the procedure.The coil detached but did not remain in the patient's body.
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
H3:product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), pin gauge sets (m-84083, m-84081) as found condition: the axium device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within a dispenser coil and within an introducer sheath.The unknown non-medtronic micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the pusher three tack welds were found broken with the release wire retracted.The distal ~0.4cm of the pusher was found kinked.The implant coil was found already detached and found damaged within the introducer sheath.Blood was found within the introducer sheath and on the axium pusher/implant.Testing/analysis: the axium implant coil could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.A large amount of blood was found within the introducer sheath and on the device, potentially contributing towards resistance.It is possible that insufficient continuous flush was used, causing blood to backflow up the micro catheter and onto the implant.Other possible causes for coil resistance in catheters include, but not limited to, lack of hydration before procedure, damaged micro catheter, or tortuous anatomy.Customer reported devices were prepared per ifu, and continuous flush was used.Therefore, the root cause could not be determined.It is possible the implant coil and pusher became damaged due to advancing against the resistance caused by the coagulated blood within the catheter or sheath.The customer report of ¿premature detachment¿ was confirmed.The tack welds were found broken, the release wire was found retracted for the pusher, and the coin was out of the lumen stop, detaching the implant as expected by the detachment subassemblies.Customer did not report any detachment attempts.It is likely the tack welds break occurred due to retracting against the resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance and premature detachment could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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: 24093241
• Report Number: 9617601-2026-00324
• Device Sequence Number: 10259096
• Product Code: KRD
• UDI-Device Identifier: 00847536037632
• UDI-Public: (01)00847536037632(17)271019(10)229927139
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/25/2026

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-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: 229927139
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2024
• 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: 68 YR
• Patient Sex: Female