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

Model Number	QC-18-40-3D
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
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 and within an introducer sheath.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The three tack welds were found broken.The axium pusher was found bent at138.0cm from the proximal end.The coin was found still against the lumen stop.The shield coil was found undamaged.The detach element was still attached to the pusher but the detach element loop was found damaged.The axium implant coil was found separated from the detach element.The implant was found stretched and damaged with the polypropylene filament broken.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed, but the cause could not be determined.Possible causes of coil stretching are, lack of hydration before procedure, user does not maintain sufficient continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance or incompatible catheter.Customer reported vessel tortuosity as minimal, and devices were prepared per ifu.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil stretching could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The tack weld was found broken, the detach element loop was found damaged and the implant was found separated from the detach element.It is possible these damages occurred due to the same issue that caused the coil stretching.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 a report that an axium coil was stretched.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the ophthalmic artery with a max diameter of 5.1mm and a 3.2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the spring coil stretched during the push-out.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.

• 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: 22245375
• Report Number: 9617601-2025-00549
• Device Sequence Number: 7803867
• Product Code: KRD
• UDI-Device Identifier: 00847536038004
• UDI-Public: 00847536038004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 07/28/2026
• Device Model Number: QC-18-40-3D
• Device Catalogue Number: QC-18-40-3D
• Device Lot Number: 227053082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 65 KG