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

Model Number	APB-3.5-10-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: vis (m-85519), 203cm ruler (m-83360) as found condition (condition of returned device): an axium prime coil and a non-medtronic headway-17 micro catheter was returned for analysis within a shipping box; within a resealable plastic bag and within a secondary resealable biohazard bag.The axium prime coil was returned without introducer sheath.Visual inspection/damage location details: no bends or kinks were found with the axium implant coil pushwire.The coin was found to be against lumen stop.The implant coil was found to be broken and returned.The implant coil was found to be stretched and damaged.No other anomalies were observed.No flash or molded voids were observed with the headway-17 hub.However, the broken distal end of implant coil was found to be stuck within hub.The catheter body was found to be flattened at ~0.5cm from distal tip.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime 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¿ was confirmed.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.It is likely the damages to the headway 17 contributed to the reported resistance.The (microvention) headway 17 micro catheter micro catheter was not returned.The headway 17 micro catheter has a labeled id (inner diameter) of 0.017¿, as per an online source.Per axium prime coil ifu (instructions for use): ¿axium prime coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.¿ therefore, the headway 17 micro catheter was found to be compatible for use with the axium prime 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
Medtronic received a report that the axium prime coil was stuck in the microcatheter during insertion.The coil did not come out of the microcatheter tip.The microcatheter was removed, and a new coil and catheter were used.The patient did not experience any health damage.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for a ruptured, saccular aneurysm located in the a1 segment of the right anterior cerebral artery.The max diameter was 4mm, and the neck diameter was 2.8mm.The patient's blood flow and vessel tortuosity were normal.Ancillary devices include a headway 17 microcatheter.Additional information received reported that the coil had come out of the introducer sheath smoothly.

• Brand Name: AXIUM PRIME BARE PL 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: 21085436
• Report Number: 9617601-2025-00035
• Device Sequence Number: 6907585
• Product Code: KRD
• UDI-Device Identifier: 00847536021273
• UDI-Public: 00847536021273
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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-3.5-10-3D-ES
• Device Catalogue Number: APB-3.5-10-3D-ES
• Device Lot Number: 228484384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• 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: 01/06/2025
• Date Device Manufactured: 03/16/2024
• 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