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

Model Number	QC-20-50-3D
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box; within an opened axium implant coil outer carton and within an opened axium implant coil inner pouch.The sl-10 microcatheter was not returned.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: the pushwire assembly was not returned.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Conclusion: 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 coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.Based on the device analysis and the reported information, the customer¿s report of ¿coil stretch¿ was confirmed as the axium implant coil was found to be stretched and damaged; however, the cause of the damage/stretch could not be determined.Possible causes are coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances or retracts the coil against resistance.There were no reported issues pushing the axium implant coil from within the introducer sheath during preparation per ifu.It is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv) subsequently causing the implant coil to become stuck.The non-med tronic micro catheter (sl-10 stryker) used in the event was not returned.The inner diameter (id) of the sl 10 microcatheter was found to be 0.0165¿ (per an online source) per axium detachable coil instructions for use (ifu): ¿axium detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.¿.Therefore, the sl 10 micro catheter was found to be compatible for use with the axium implant coil and can be ruled out as a potential cause.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 involving the bare axium 3d coil, the physician encountered resistance while pushing the coil through the microcatheter.The coil became stuck in the middle of the catheter and was subsequently removed.Upon removal, the coil appeared fully stretched and resembled a thin strand.The coil was replaced with another coil, which was successfully deployed using the same microcatheter.The coil was noted to be damaged at the implant coil location.The catheter was not damaged.Additional information received reported no patient symptoms.The cause of the resistance/stretch was not determined.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.There was no kink/damage to the catheter observed after removal.There were no issues that resulted in the damage that was found.Ancillary devices used: excelsior sl-10 microcatheter.

• 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: 21701905
• Report Number: 9617601-2025-00299
• Device Sequence Number: 12710174
• Product Code: KRD
• UDI-Device Identifier: 00847536038011
• UDI-Public: 00847536038011
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: 63475
• 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): 03/26/2025

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-20-50-3D
• Device Catalogue Number: QC-20-50-3D
• Device Lot Number: 228045507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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 Sex: Unknown