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

Model Number	APB-1-3-3D-ES
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Stretched (1601); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/10/2025
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Medtronic received a report that after detaching the coil, the microcatheter was withdrawn and the coil was pulled out of the aneurysm.It was found that the proximal segment of the coil was not visible under fluoroscopy, suspected to be a "invisible coil".The proximal segment was left on the parent artery.It was noted that coil stretch occurred.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a ruptured, saccular, left anterior communicating artery aneurysm with a max dia meter of 4 mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There was no friction or difficulty during testing or delivery, continuous flush was administered during the procedure, the damaged/stretched location on the device was the implant coil, and the physician did not reposition the coil during the procedure.
Additional Manufacturer Narrative
Update b5 and e2.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
Additional information was received.No actions or interventions were taken to resolve the coil migration into the parent vessel post deployment.The procedure was completed by directly withdrawing the microcatheter, and the coil was not replaced with a new medtronic product.The cause of coil stretch and poor visualization was confirmed through imaging, and no issues were identified that resulted in the observed damage.The patient did not receive, and will not require, any medical or surgical intervention as a result of the coil migration.No antiplatelet regimen was administered before or after the procedure.Ancillary devices include a echelon catheter 145-5091-150, lot number: 0231121180).

• 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: 23535754
• Report Number: 9617601-2025-02690
• Device Sequence Number: 21374215
• Product Code: KRD
• UDI-Device Identifier: 00763000313623
• UDI-Public: (01)00763000313623(17)280118(10)230462868
• 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): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APB-1-3-3D-ES
• Device Catalogue Number: APB-1-3-3D-ES
• Device Lot Number: 230462868
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/10/2025
• Date Device Manufactured: 01/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male