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

Model Number	QC-5-20-HELIX
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	08/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil experienced resistance in the echelon catheter.The patient was undergoing surgery for treatment of a saccular, ruptured left anterior communicating artery aneurysm with a max diameter of 5 mm and a 4 mm neck diameter.The access vessel was the femoral artery with a 10 mm diameter.It was noted the patient's blood flow was normal and the vessel tortuosity was severe.It was reported that after the echelon microcatheter was positioned, an attempt was made to deliver the axium coil, but the coil could not come out, and significant resistance was encountered during delivery.The surgeon indicated that there might be issues with both the microcatheter and the coil.After replacing the microcatheter, the coil was successfully delivered.The surgeon attempted to re-deliver the first axium coil into the aneurysm but found that the coil was already deformed.The surgery was successfully completed afterward, but the surgeon indicated that both products had issues.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per the ifu.No patient symptoms or complications were associated with this event.Ancillary devices include an echelon 10 catheter.Additional information received the resistance was located in the middle of the catheter.The coil came out of the introducer sheath smoothly.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), in-house coil (model: pv-20-50-helix lot: b437578) as found condition: the echelon-10 micro catheter and axium device were returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within their dispenser coils.The axium device was returned further within its introducer sheath.Visual inspection/damage location details: no flash or hub mold were found within the hub.No damages or irregularities were found with the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter body or proximal marker band.The distal marker band was found crushed (figure f).The distal tip was found ovalized (figure g).The axium pusher was found kinked at ~165.5cm from the proximal end.The axium implant coil was found stretched and damaged within the introducer sheath with the polypropylene filament broken (figures j, k & l).Testing/analysis: the echelon-10 total length (to the proximal marker band) was measured to be ~153.0cm and the usable length (to the proximal marker band) was measured to be ~145.2cm, which is within specification (specification: total (ref) = 152cm; usable = 144cm ± 1.5cm).The echelon-10 micro catheter was flushed, and water was found to exit the tip.An in-house coil was inserted into the echelon-10 catheter hub, through the catheter body and became stuck at the damaged distal marker band.The axium device could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer report of ¿catheter resistance¿ and ¿coil resistance/stuck in catheter¿ were confirmed.The cause of the resistance during analysis was found to be due to the crushed marker band.Possible causes for catheter crushing include, but not limited to, patient vessel tortuosity, catheter entrapment, user advances/retrieves device against resistance.Customer reported resistance was encountered in the middle micro catheter, which could not be confirmed.The axium pusher was found kinked and the implant was found stretched/damaged.It is possible the damages occurred due to advancing/retracting against the reported resistance.Other possible causes for coil stretching include, but not limited to, 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, or pusher rotation.Customer reported vessel tortuosity as severe, devices were prepared and flushed per ifu, and coil came out of sheath smoothly during preparation.It is possible the reported severe tortuosity contributed towards the resistance and damages.The axium device is compatible for use with the echelon-10 micro catheter.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 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: 23468292
• Report Number: 9617601-2025-02497
• Device Sequence Number: 8807701
• Product Code: KRD
• UDI-Device Identifier: 00847536037427
• UDI-Public: (01)00847536037427(17)261008(10)227484393
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/04/2025

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 Model Number: QC-5-20-HELIX
• Device Catalogue Number: QC-5-20-HELIX
• Device Lot Number: 227484393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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: 56 YR
• Patient Sex: Female