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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the axium prime bare 3d 3mm x 6cm extra soft coil encountered resistance at the catheter hub when attempting to insert the coil into the catheter.The device and any accessory devices were prepared as indicated in the instructions for use.As a result of the resistance, the coil was not used, and another axium coil was utilized instead.There was no patient involvement.The catheter was not manufactured by medtronic.Additional information received reported the coil pushed out of the introducer sheath smoothly.There was no kink or other damage observed to the coil or the catheter.The cause of the resistance was unknown.
Additional Manufacturer Narrative
This event is reported conservatively at this time based on analysis findings for which a possibly reportable event cannot be ruled out.H3.Product analysis: equipment used: vis m-81805, 203cm ruler m-83360 as found condition (condition of returned device): the axium prime implant coil was returned for analysis within a shipping box and returned within a sealed plastic biohazard pouch.No microcatheter was returned.Damage location details: the axium prime implant coil was returned without the introducer sheath.The pushwire was found to be bent at ~5.4cm, bent at ~84.7cm, and bent at ~131.7cm from the proximal end.The axium prime implant coil was detached.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coil could not test with an in-house microcatheter due to the returned con dition(damaged).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in cath hub¿ was unable to be confirmed and the root cause was unable to be determined as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible causes for coil resistance are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, failure to use a compatible microcatheter for delivery, and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).The customer reported that the device and any accessory devices were prepared as indicated in the instructions for use.No information regarding the microcatheter used in the event was provided; therefore, compatibility was unable to be assessed.It is likely that the damage to the implant coil and the pushwire occurred during the attempt to push the coil through the microcatheter against the reported resistance.However, the cause of resistance 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 PRIME BRPL 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: 21287439
• Report Number: 9617601-2025-00133
• Device Sequence Number: 18133152
• Product Code: KRD
• UDI-Device Identifier: 00847536021235
• UDI-Public: 00847536021235
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• 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): 01/31/2025

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: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 228588214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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