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

Model Number	APB-3-4-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that when detaching the coil, the rear end of the delivery pusher was inserted into the slot of the instant detacher, but resistance was encountered, and it could not be inserted sufficiently.Normal detachment was performed until insertion was possible, however, detachment was not possible, so the coil was detached by force detachment.The physician attempted to detach the coil with the instance detacher 2 tiems.The physician did to attempt to use another instant detacher.There was attempt to detach the device with hypotube.There were defects wit hthe instant detacher.The devices were prepared as indicated in the package insert.The patient was being treated for a ruptured, saccular aneurysm in the basil artery tip.The max diameter was 9.0mm and the neck diameter was 6.0mm.Bllod flow speed was normal and vessel tortuosity was moderate.No patient symptoms or complications were reported.Additional information received reported no pushwire damage after removal from the patient.Prior to coil non-detachment, no issues were encountered.The first coil (lot: 228781478) could not be removed, so a forced separation was performed; the second coil (lot: 228893130) was also tested, but it could not be removed, so forced separation was performed.
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.

• 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: 21922532
• Report Number: 9617601-2025-00431
• Device Sequence Number: 9031421
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203432
• 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): 04/28/2025

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-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 228893130
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 05/21/2024
• 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: Male