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

Model Number	QC-2-6-3D
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil hoop could not be formed.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right posterior communicating artery with a max diameter of 5.2 mm and a 2.9 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that for right posterior communicating artery aneurysm, after the microcatheter was delivered into place through the guide wire, qc2-6-3d was used as the coil to form the hoop.After repeated adjustments after entering the aneurysm, the hoop could not be formed, so it was removed from the body and replaced with a new qc2-6 spring coil, and then the hoop was formed smoothly.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Additional information was received that the cause of the poor shape/inability to form a hoop was not determined.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5), as found condition: the axium coil was returned for analysis within shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.The already detached implant coil was returned further within a resealable plastic pouch.Visual inspection/damage location details: the axium pusher was found broken at the positive load indicator with the two segments retained by the release wire.The coin was found fully retracted out of the lumen stop.The shield coil was found undamaged.The already detached implant coil was found damaged.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil shape ¿ poor shape outside sheath¿ could not typically be confirmed through device analysis and customer did not submit any images or videos for review.In addition, poor coil shape is usually observed during preparation or during filling of the aneurism.The implant coil was found damaged, potentially contributing to the poor shaping.It is likely the coil became damaged due to advancing against resistance.The pusher was found broken, the release wire/coin were found retracted, which would detach the implant coil as expected by the detachment subassemblies.The cause of the break could not be determined.Customer did not report any detachment attempts.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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19551605
• Report Number: 9612164-2024-02862
• Device Sequence Number: 6806255
• Product Code: KRD
• UDI-Device Identifier: 00847536037632
• UDI-Public: 00847536037632
• 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
• Report Date (Section B): 06/17/2024

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: 05/28/2025
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: 224432209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2022
• 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: 52 YR
• Patient Sex: Male