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

Model Number	QC-1.5-2-HELIX
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
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
Medtronic received a report that during deployment of the last axium coil in aneurysm, coil accidentally broke and a part of coil is outside aneurysm (in carrying vessel).The doctor used a snare to take that part of coil outside but can not do it.Luckily, that part of the coil is close to wall of vessel.They had to use antiplatelet and closely follow up, the device remained in the patient.A part of coil is going out of aneurysm and patient is using antiplatelet.The reported device and any accessory devices were prepared as indicated in the ifu.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician had repositioned the coil "several times." the physician did not attempt to detach the coil.  ancillary devices included an echelon microcatheter.
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 received reported that there were no detachment attempts made with the instant detacher since the coil accidentally broke during the procedure.The physician was closely following up with the patient.
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 device was returned for analysis within a shipping box; within an opened axium outer carton; within an opened axium inner pouch and within an introducer sheath.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.The axium pusher was found kinked at ~155.0cm (figure c) from the proximal end.The coin was found still against the lumen stop, the shield coil was found undamaged, and the implant coil was found broken from the pusher at the detach element (figure d).Customer reported the implant remained within the patient.Testing/analysis: n/a conclusion: based on the analysis performed, the customer report of ¿coil separation/break" was confirmed.Possible causes for coil break include, but not limited to, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or user advances device against resistance.Customer reported devices were prepared per ifu, pushwire was not bent or broken, no friction/difficulty during delivery, and device was repositioned several times.The multiple repositioning potentially could have contributed towards the failure; however, the likely cause could not be identified.As the echelon-10 micro catheter was not returned for analysis, any contribution of the micro catheter to the premature detachment could not be determined.The echelon-10 micro catheter is compatible for use with the axium device.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 HELIX
• 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 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19961046
• Report Number: 9612164-2024-03672
• Device Sequence Number: 20626578
• Product Code: KRD
• UDI-Device Identifier: 00847536037229
• UDI-Public: 00847536037229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QC-1.5-2-HELIX
• Device Catalogue Number: QC-1.5-2-HELIX
• Device Lot Number: 227675472
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 01/21/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/14/2024; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown