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 Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after the coil embolization was completed, during detachment, the operator manually broke off the detachment area but could not find the detachment wire.Only by using surgical forceps to break off the middle section of the push rod and remove the detachment wire could the coil be successfully detached.The product was replaced with a medtronic product to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of a ruptured, saccular, right ophthalmic artery segment aneurysm with a max diameter of 7 mm and a 4 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
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
Updated b5, d9.H3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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.No causes or contributing factors for the detachment issue were identified.One attempt was made to detach the coil using the manual method, and no attempts were made using the instant detacher; therefore, no instant detacher lot number is applicable.No issues were encountered prior to the coil non detachment.Additionally, no pushwire damage was observed after removal from the patient.
Additional Manufacturer Narrative
Product analysis as found condition- the axium device was returned for analysis within a shipping box and inside of a sealed plastic biohazard pouch.No instant detacher or microcatheter were returned.Visual inspection/damage location details ¿ the proximal end (actuator interface and positive load indicator) were only returned.No release wire, implant coil, introducer sheath, or remining pushwire was returned.No other anomalies were observed.Testing/analysis ¿ none.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was unable to be confirmed; and no root cause was able to be determined.Only the broken proximal tip was returned for assessment.The rest of the device was not retuned; therefore, no further testing was able to be performed.It was noted that the patient's blood flow was normal and vessel tortuosity was moderate.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).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: 24557779
• Report Number: 9617601-2026-01698
• Device Sequence Number: 15660633
• Product Code: KRD
• UDI-Device Identifier: 00847536037816
• UDI-Public: (01)00847536037816(17)280329(10)230911108
• 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,Followup
• Report Date (Section B): 05/11/2026

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-5-15-3D
• Device Catalogue Number: QC-5-15-3D
• Device Lot Number: 230911108
• 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: 03/08/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/15/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 75 KG