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

Model Number	APB-1-2-3D-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	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 on april 27, a patient with an intracranial c7 aneurysm was treated.After completion of diagnostic angiography, access was established using a 6f intracranial support catheter, a 27 microcatheter, and an echelon microcatheter.After the 27 stent catheter and the echelon microcatheter were positioned, a ped-375-20 was advanced and partially deployed.A prime 3d 1-4 coil was then placed into the echelon microcatheter, but after the coil was delivered into the microcatheter, it could not come out.Subsequently, a prime 3d 1-2 coil was opened instead, which also could not be advanced into the echelon microcatheter.Suspecting an issue with the microcatheter, it was replaced with another echelon microcatheter (105-5091-150).The prime 3d 1-4 coil was then successfully advanced through the microcatheter and used to embolize the aneurysm; however, detachment was unsuccessful after two attempts.The coil was subsequently replaced with a prime 3d 1-2, which also could not be detached.After replacing it again with another prime 3d 1-2 coil, embolization and detachment were successful.The flow-diverting stent was deployed at the same time, the procedure was completed successfully, and the patient experienced no adverse reactions.The device and any accessories were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Additional information received.No causes or contributing factors for the event were identified.The lesion characteristics were reported as a c7 segment sidewall aneurysm.The patient¿s vessel tortuosity was moderate.Continuous catheter flush was administered during the procedure.Only 2 coils had device issues.For the prime 3d 1-4 coil, resistance was encountered at the distal portion of the catheter.The coil came out of the introducer sheath smoothly.No kink or damage to the coil or the catheter was observed after removal.No attempts were made to detach the coil using the instant detacher; all attempts utilized mechanical detachment.More than two attempts were made using the manual method.Prior to the non-detachment, the issue encountered was that the coil initially failed to come out within the microcatheter.No pushwire damage was observed after removal from the patient.For the prime 3d 1-2 coil, resistance was encountered at the distal portion of the catheter.The coil came out of the introducer sheath smoothly.Continuous catheter flush was administered during the procedure.No kink or damage to the coil or the catheter was observed after removal.No attempts were made to detach the coil using the instant detacher.More than two attempts were made using the manual method.Prior to the non-detachment, the issue encountered was that the coil failed to come out within the microcatheter.No pushwire damage was observed after removal from the patient.

• 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: 25340778
• Report Number: 9617601-2026-03500
• Device Sequence Number: 20088052
• Product Code: KRD
• UDI-Device Identifier: 00763000313616
• UDI-Public: (01)00763000313616(17)280821(10)232007208
• 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,Followup
• Report Date (Section B): 06/08/2026

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-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: 232007208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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