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 Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 145-5091-150 (lot: 0229010515); product type: ; implant date n/a; explant date n/a product id id-1-5 (lot: unknown); product type: ; implant date n/a; explant date n/a.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 an aneurysm embolization procedure to treat an unruptured saccular aneurysm located in the internal carotid artery, the tip of the echelon 10 45° pre-shaped tip microcatheter was damaged after shaping.The access vessel was the femoral artery, and vessel tortuosity and blood flow were described as normal.The microcatheter was replaced, and the procedure continued successfully.Additionally, the bare axium 3d coil could not be detached during the same procedure.The coil was replaced, and the replacement coil was successfully implanted.There were no reported patient symptoms or complications associated with these events, and the patient outcome was reported as alive with no injury.The devices were prepared and flushed as indicated in the 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.
Event or Problem Description
Additional information received that the catheter was fumigated for about 30 seconds.The catheter was about 5 cm away was the steam source.Prior to coil non-detachment, there were no issues encountered.The cause of the catheter damage was not determined.The cause of the non-detachment was not determined.
Additional Manufacturer Narrative
H3: product analysis as found condition- the axium device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.There is no evidence of detachment attempts using an instant detacher at this location.The break indicator was found unbroken.No evidence of manual detachment attempt was found at this location.The axium pusher was found bent at ~3.5cm and ~57.0cm from the proximal end.The coin was found still against the lumen stop.Blood was found under the ptfe shrink tubing and within the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found to be damaged and stretched with the polypropylene filament broken.Testing/analysis ¿ an in-house instant detacher failed to detach the implant as the release wire/coin were stuck within the pusher/lumen stop.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved in an ultrasonic cleaner.The release wire was retracted, and the coin exited the lumen stop with no issues and no resistance encountered.Residual blood was found still within the lumen stop.The implant coil became detached.The coin was damaged during the extraction attempts.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachment is the blood found within the lumen stop and under the jacket causing the coin to become stuck within the lumen stop.The implant detached once the blood was dissolved during analysis.It is not known how much the blood had coagulated within the device during the procedure.The implant coil was found damaged/stretched, possibly caused by advancing against resistance or handling after retracted back out.As the instant detacher used during the event was not returned for analysis, any contribution of the instant detacher to the non-detachment 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: 21080182
• Report Number: 9617601-2025-00032
• Device Sequence Number: 8498015
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: 00847536037625
• 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): 03/25/2025

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 Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 228241443
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/09/2025; 02/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/30/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: 50 YR
• Patient Sex: Male