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

Model Number	QC-10-30-3D
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for a saccular, unruptured posterior communicating artery aneurysm of the internal carotid artery with a max diameter of 14mm and a 7mm neck diameter.It was noted that the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the surgeon used a axium coil to embolize the aneurysm, but the coil could not be detached.The surgeon then replaced it with another coil of the same model, which successfully embolized and detached.The reported device and any accessory devices were prepared as.
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
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.The cause of the reported non-detachment could not be determined.No attempts were made to detach the coil using the instant detacher, while two attempts were made using the manual method.The instant detacher lot number was not available.Prior to the coil non-detachment, no issues were encountered, and the procedure was reported to have gone smoothly.Manual detachment was ultimately performed, during which the surgeon broke the detachment point and observed that the pushwire appeared damaged after removal.
Additional Manufacturer Narrative
Product analysis: as found condition- the axium device was returned within a shipping box, within a sealed plastic biohazard pouch, within an opened axium inner pouch, within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the axium pusher was found broken distal to the break indicator with the release wire also broken at the same location.The proximal segment (including the actuator interface, positive load indicator and break indicator) was not returned for analysis.The pusher was found bent at ~89.2cm and ~66.4cm from the proximal end.The axium implant coil was still attached to the pusher.Dried blood was found within the introducer sheath and on the implant coil.Once removed from within the introducer sheath, the ptfe shrink tubing was found damaged/broken.The coin was found still against the lumen stop.Blood was found within the shrink tubing and within the lumen stop (figure h).Once the blood was dissolved, the coin was found broken and stuck within the lumen stop.The stuck coin was removed using a tweezer against resistance, detaching the implant.The lumen stop was found damaged testing/analysis ¿ the distal coin segment was lost during the extraction due to its small size and could not be measured.The lumen stop inner diameter could not be measured due to the damaged condition.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.The cause of the non-detachment was found to be due to the coin stuck within the lumen stop.The lumen stop was found damaged, further indicating that the coin was jammed within the inner diameter of the lumen stop, preventing the implant from detaching.Dried blood was found within the lumen stop, potentially contributing to the coin/release wire failing to retract out of the lumen stop.It is not known the level of blood coagulation during the procedure.The release wire (proximal) and the coin were found broken.It is likely the coin/release wire broke due to the attempt to retract the release wire while the distal release wire and coin were stuck within the lumen stop.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: 22629998
• Report Number: 9617601-2025-00704
• Device Sequence Number: 9251295
• Product Code: KRD
• UDI-Device Identifier: 00847536037946
• UDI-Public: (01)00847536037946(17)280201(10)230574124
• 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): 10/06/2025

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-10-30-3D
• Device Catalogue Number: QC-10-30-3D
• Device Lot Number: 230574124
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 09/15/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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 Sex: Male