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

Model Number	QC-6-20-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id id-1-5 (lot: unknown); implant date n/a; explant date n/a product id qc-5-15-3d (b)(6); 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
It was reported that during a procedure to treat an unruptured fusiform aneurysm in the middle cerebral artery, there was a non-detachment issue with two bare axium 3d coils.The coils, models qc-6-20-3d and qc-5-15-3d, were positioned inside the aneurysm, but several attempts to detach them were unsuccessful.The patient's blood flow was normal, and the vessel tortuosity was moderate.No manual detachment attempts via hypotube were confirmed.A second instant detacher was not used.The instant detacher was discarded, and there were no issues reported with it.The coils were never implanted.The patient did not experience any injury or complications.
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 that the coil was attempted to be detached with the detacher 8 times.There was no attempt with the manual method.Prior to coil non-detachment, there were no issues encountered.There was no pushwire damage observed after removal from the patient.The cause of the event was not determined.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) document used: n/a as found condition (condition of returned device): two axium implant coils were returned for analysis within a shipping box; within their opened axium implant coil outer cartons; within their axium implant coil inner pouches and within individual dispenser tracks.Visual inspection/damage location details: (pli-10) the axium pusher was returned within the introducer sheath.The actuator interface was found to be intact and attached to the coupler tube.There did not appear to be evidence of mechanical detachment using an instant detacher at this location.No bends or kinks were found with the axium coil pushwire.This is indicative manual detachment attempts were not made.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant was found to be stretched and damaged.No other anomalies were observed.(pli-20) the axium pusher was returned within the introducer sheath.The actuator interface was found to be intact and attached to the coupler tube.There did not appear to be evidence of mechanical detachment using an instant detacher at this location.No bends or kinks were found with the axium coil pushwire.This is indicative manual detachment attempts were not made.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): (pli-10) no difficulty was experienced inserting the pushwire into the instant detacher, and the load indicator was not visible when the pushwire was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.(pli-20) no difficulty was experienced inserting the pushwire into the instant detacher, and the load indicator was not visible when the pushwire was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.Conclusion: based on the analysis performed, the customer report of ¿non-detachment¿ was confirmed as the pusher was returned with the implant coil still attached.However, the implant coils were successfully detached mechanically during testing.The root cause could not be determined for the non-detachment.The implant coil was found damaged.Possible causes for coil damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its dispenser coil.Since the instant detacher was not returned, any contributing factors of the instant detacher to 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 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: 20715889
• Report Number: 9617601-2024-00313
• Device Sequence Number: 9903510
• Product Code: KRD
• UDI-Device Identifier: 00847536037847
• UDI-Public: 00847536037847
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 02/03/2025

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: 06/11/2025
• Device Model Number: QC-6-20-3D
• Device Catalogue Number: QC-6-20-3D
• Device Lot Number: 224521004
• 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: 11/16/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 01/13/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/11/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Male