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

Model Number	APB-3-8-3D-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
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 prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and partially within an introducer sheath.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath and axium prime pusher.The axium prime implant coil was found stretched and damaged within the introducer sheath (figure c) as well as outside the introducer sheath (figure d).The implant coil tip was found still attached to the implant, indicative the coil did not break (figure e).Testing/analysis: the axium prime coil could not be retracted back within the introducer sheath as it was found stuck.The axium prime coil could not be used for resistance testing due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter, incompatible micro catheter, or tortuous anatomy.Customer reported vessel tortuosity as minimal, continuous flush was administered, and no damages were found with the micro catheter.Therefore, the likely cause could not be determined.The returned axium prime implant coil was confirmed to have ¿coil stretch¿.The customer reported the coil came out of the introducer sheath smoothly during preparation and did not report any damages found to the coil during preparation, therefore, it is likely the damage occurred due to advancing against the reported resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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 a ruptured saccular aneurysm in the right internal carotid artery ophthalmic artery, there were issues with the axium prime bare 3d coil.The coil encountered significant resistance while being pushed through the microcatheter and became stuck in the middle of the catheter.Upon withdrawal, it was observed that the coil had stretched.The aneurysm had a maximum diameter of 6 millimeters and a neck diameter of 3 millimeters, with normal blood flow and minimal vessel tortuosity.Continuous flush was administered during the procedure.The coil was not repositioned, and the catheter was not damaged.The coil was damaged at the implant coil location.The product was never implanted and was replaced by another medtronic product.Additional information received reported that the cause of the resistance/stretch was not determined.The coil came out of the intro ducer sheath smoothly.

• 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: 21395430
• Report Number: 9617601-2025-00179
• Device Sequence Number: 12893254
• Product Code: KRD
• UDI-Device Identifier: 00763000313746
• UDI-Public: 00763000313746
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/17/2025

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-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: 227969703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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: 79 YR
• Patient Sex: Female