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

Model Number	APB-6-15-3D-SS
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	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reported at this time based on analysis findings which indicate a reportable event.H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), (model: qc-4-12-helix lot: a137432) as found condition: the echelon-10 micro catheter and two axium prime devices were returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a sealed tyvek biohazard pouch and within their dispenser coils.The devices were labeled on their dispenser coils.The two axium prime devices were returned further partially within their introducer sheath.The first axium prime and the echelon-10 will be addressed together and the second axium prime will be addressed separately.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium prime pusher.The implant coil was found severely stretched outside and within the introducer sheath with the polypropylene filament broken.No damages or irregularities were found with the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter body, distal tip, or marker bands.Testing/analysis: the echelon-10 total length (up to the proximal marker band) was measured to be ~152.5cm and the useable length (up to the proximal marker band) was measured to be ~144.8cm which is within specification (specification: total (ref) = 152cm; usable = 144.0 cm ± 1.5cm).The echelon-10 micro catheter was flushed, water exited from the distal tip.An in-house coil was inserted into the echelon-10 micro catheter hub but was unable to pass through the hub as it became stuck at the fuse joint between grilamid and catheter shaft.The outer strain relief was removed, and a gap was confirmed between the hub and the catheter shaft.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ and ¿catheter resistance¿ were confirmed.The cause of the resistance within the hub with the echelon-10 micro catheter was found to be the gap between the hub and micro catheter body.A gap in the hub is formed when grilamid (nylon tubing) is not fully seated against the hub when fused on to the catheter during hub assembly.It is likely the resistance caused by the gap contributed towards the coil damage.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review will be performed.The resistance caused by the gap would contribute towards the coil damages/stretches found.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 after the first spring coil 6-15 entered the microcatheter, it could not be pushed or withdrawn.The whole was withdrawn from the body.The microcatheter and the spring coil body were found to be damaged.It  was replaced with a new microcatheter and the spring coil was delivered.When delivering the 2.5-4 spring coil, the resistance was found to be larger, and the spring coil was withdrawn from the body and the coil body was found to be damaged.Resistance had been in the middle segment of the catheter.There were no symptoms reported.The device and any accessory devices were prepared as indicated in the ifu and the catheter was flushed as indicated in the ifu.The patient was being treated for a saccular, unruptured aneurysm in c4 with a max diameter of 6mm and a neck diameter of 2mm.Blood flow was normal and vessel tortuosity was minimal.Access vessel was the femoral artery with a 10mm diameter.Additional information received that the cause of the resistance/damage was not determined.The coil came out of the introducer sheath smoothly.Besides the resistance, there were no other issues that resulted in the damage that was found.

• 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: 21118887
• Report Number: 9617601-2025-00052
• Device Sequence Number: 20753008
• Product Code: KRD
• UDI-Device Identifier: 00847536038295
• UDI-Public: 00847536038295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/09/2025

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-6-15-3D-SS
• Device Catalogue Number: APB-6-15-3D-SS
• Device Lot Number: 228893088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 56 KG