MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-3-6-3D
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-echelon (lot: unknown); product id qc-2-6-3d (227529260); 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
Max diameter 3.5 mm and neck diameter 4 mm.The patient's blood flow and vessel tortuosity was normal.The patient had anterior communicating artery aneurysm and was planned to undergo aneurysm embolization.After selecting the appropriate angle, the echelon-10 catheter was placed into the aneurysm cavity, and then the navien catheter was passed through.With the cooperation of the micro-guidewire, the embolization catheter was used to deliver and fill the spring coils qc-6-20-3d and qc-5-15-3d, and then qc-3-6-3d.During the delivery process, it was found that the spring coil could not be detached during the operation, so the spring coil was replaced and the operation continued.During the filling of qc-2-6-3d, it was found that the spring coil could not be pushed out of the microcatheter, so a product of the same specification was replaced and deployed.Cerebral angiography showed that the parent artery was unobstructed, and the microcatheter and micro guidewire were withdrawn.Anteroposterior and lateral angiography were performed, which showed that the branches of the internal carotid artery were well visualized.There were no patient symptoms or complications associated with this event.
Event or Problem Description
Additional information received reported continuous saline flush was administered and maintained 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
H3: product analysis # (b)(4): equipment used- video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs50520 rev.U.As found condition- the axium prime device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within its introducer sheath.The already detached implant coil was returned further within a resealable plastic pouch.A second axium prime device was also returned and will be addressed in pli-10.Visual inspection/damage location details: the axium prime pusher was found broken at the break indicator with the release wire retracted out of the distal pusher segment (figure d), indicative of a manual detachment at this location.The release wire was found separated/broken from the actuator interface with the actuator interface and proximal pusher segment not returned for analysis.No damages or irregularities were found with the remaining pusher.The coin was found fully retracted out of the lumen stop (figure e).The shield coil was found undamaged.The coin was found undamaged.The lumen stop was found damaged (figure g).The already detached implant coil was found undamaged.Testing/analysis ¿ the exposed release wire was retracted, and the release wire/coin moved/exited freely from within the pusher.The coin was measured to be 0.087mm @ 0.063mm, 0.102mm @ 0.127mm, and 0.105mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).The lumen stop inner diameter could not be reliably measured due to the damaged condition.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the implant was returned already detached but the event likely had occurred.The lumen stop was found damaged on two opposing sides, indicative that the coin was jammed within the inner diameter of the lumen stop.The stuck coin in lumen stop would have caused the release wire to not retract and caused the implant to not detach.The cause of the coin stuck within lumen stop could not be confirmed.There was no non-conformance to specifications that would contribute towards the stuck coin and subsequent non-detachment.The proximal pusher segment and instant detacher used in the event was not returned.Therefore, any contribution of the proximal pusher and instant detacher towards the non-detachment could not be determined.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; 9775 toledo way; irvine CA 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; 9775 toledo way; irvine CA 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21620217
• Report Number: 9617601-2025-00247
• Device Sequence Number: 15564897
• 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: 09/10/2026
• Device Model Number: QC-3-6-3D
• Device Catalogue Number: QC-3-6-3D
• Device Lot Number: 227286474
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 05/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/11/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2023
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 67 KG