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

Model Number	QC-4-12-3D
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the axium coil revealed that the axium implant coil pushwire was found to be kinked at ~165.0cm from proximal end.The implant coil was found to be stretched within and out of introducer sheath.The coil was unable to be pushed out from within the introducer sheath for further evaluation as it was found to be stuck within the introducer sheath.All other subassemblies appeared to be normal, and no other anomalies were observed.The axium implant coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium implant coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and the reported information, the customer¿s report of ¿pusher kink/damage¿ was confirmed as the axium pusher was found to be kinked; however, the cause of the damage 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.
Event or Problem Description
Medtronic received a report that an axium coil was stuck in the middle of the catheter.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured right posterior inferior cerebellar artery aneurysm with a saccular morphology.Aneurysm dimension: max diameter 6 mm and neck diameter 4 mm.The patient¿s blood flow was normal and vessel tortuosity was minimal.The treatment plan was a stent placement plus a coil embolization.The catheter was sent to the distal end of the posterior inferior cerebellar artery and the microcatheter was inserted into the aneurysm.The axium coil was hydrated and sent into the microcatheter.When delivered into the microcatheter, the surgeon indicated that there was resistance and was difficult to push.After withdrawing the coil, it was found that the proximal push rod of the coil was kinked.Then coil was replaced and the procedure was completed.There were no patient symptoms or complications associated with this event.Additional information was received that the cause of the resistance was not determined.

• 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: 18943327
• Report Number: 9612164-2024-01347
• Device Sequence Number: 20933964
• Product Code: KRD
• UDI-Device Identifier: 00763000320997
• UDI-Public: 00763000320997
• 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
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 02/05/2025
• Device Model Number: QC-4-12-3D
• Device Catalogue Number: QC-4-12-3D
• Device Lot Number: 223745235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2022
• 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: 59 YR
• Patient Sex: Female