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

Model Number	APB-2-4-3D-ES
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 coils stuck/resistance occurred in the middle of the echelon catheter.The catheter was damaged at unknown location, and the coils was damaged at pushwire middle segment.The patient was undergoing treatment of a saccular, ruptured anterior communicating artery aneurysm with a max diameter of 3 mm and a 1.5 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.The access vessel was the femoral artery, with 8mm diameter.It was reported that after positioning the intermediate catheter, the echlenon10 microcatheter (batch: 0229906497) was advanced to the lesion site.The first coil, apb-2-4-3d-es (batch: 229115231), was selected, and the surgeon reported slight resistance during delivery but successfully deployed and detached the coil.Fluid infusion was checked and found to be functioning normally.The second coil, apb-1.5-3-3d-es (batch: 229655742), encountered significant resistance near the proximal end of the microcatheter during delivery.The coil's pusher wire became bent, leading the surgeon to suspect a coil quality issue.Since the same model was unavailable, apb-1-1-hx-es was selected as a replacement.However, during delivery, high resistance was again observed, and upon attempting to retrieve the coil, it stretched inside the microcatheter.The surgeon was unable to determine whether the issue was with the microcatheter or the coil.Ultimately, a microcatheter and coils from another manufacturer were used, allowing the successful delivery and detachment of two coils.The patient experienced no complications, and the procedure was completed successfully.Both the microcatheter and the two coils were submitted for complaint processing.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received stating that the cause of the catheter resistance was not determined.Regarding the cause of the three used coils resistance and catheter damage, the surgeon considered it to be a problem with the quality of the microcatheter.The coil damage may have been caused by the resistance of the microcatheter during delivery.The catheter damage observed was kinking.The coil came out of the introducer sheath smoothly.The coil damage observed was a breakage.The coil apb-1-1-hx-es, lot#: 229175967 was accurate.

• 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: 22545703
• Report Number: 9617601-2025-00659
• Device Sequence Number: 21014415
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: (01)00763000313692(17)270705(10)229115231
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 229115231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 07/05/2024
• 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: 69 YR
• Patient Sex: Female