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

Model Number	QC-3-6-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
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 report that the axium coil detached prematurely.It was noted that the coil and all accessory devices were prepared as indicated in the instructions for use (ifu).  there was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a c5 vessel segment unruptured saccular aneurysm that had a max diameter of 3mm and neck diameter of 2.1mm.Patient's blood flow and vessel tortuosity were normal.
Event or Problem Description
Additional information received reported that there were no detachment attempts made with either the instant detacher or the manual method.
Additional Manufacturer Narrative
H3: device received, analysis is in progress.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 as found condition: the axium device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened axium inner pouch and outside its returned introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.The axium pusher was found broken at 139.2cm from the proximal end with the release wire fully retracted out of the distal segment.The release wire was found damaged throughout the length.The distal pusher segment was found kinked at 2.2cm from the distal end.The coin was fully retracted out of the lumen stop.No damages or irregularities were found with the coin.The shield coil was found undamaged.The implant coil was already detached and not returned for analysis.The retainer ring was found damaged.Testing/analysis: the coin was measured to be 0.074mm @ 0.063mm, 0.091mm @ 0.0127mm, and 0.097mm @ 0.0275mm; which is within spec ification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.0105mm @ 0.0127mm; and 0.086mm ¿ 0.0108 @ 0.0275mm) no other anomalies were observed.The inner diameter of the retainer ring could not be reliably measured.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was confirmed.The implant likely detached due to the pusher break and the release wire/coin retracted out of the pusher/lumen stop.The cause of the break could not be determined.As the pusher was also found kinked and the retainer ring was found damaged, it is possible the damages occurred due to advancing/retracting against resistance.It is possible the damaged retainer ring contributed towards the premature detachment.The release wire was found damaged, however, it is possible it became damaged during handling/return to medtronic as the release wire was returned outside the pusher and easily damaged.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: 21575750
• Report Number: 9617601-2025-00234
• Device Sequence Number: 18250404
• Product Code: KRD
• UDI-Device Identifier: 00847536037694
• UDI-Public: 00847536037694
• 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): 05/21/2025

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 Expiration Date: 01/13/2026
• Device Model Number: QC-3-6-3D
• Device Catalogue Number: QC-3-6-3D
• Device Lot Number: 225769265
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 05/01/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/08/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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