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 Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: equipment used: vis m-81805, 203cm ruler m-83360.As found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box and inside of a sealed plastic biohazard pouch.Damage location details: the axium prime device was returned damaged, with no introducer sheath.The pushwire was found to be bent at ~3.2cm, kinked (with the release wire pulled) at ~8.3cm, bent (damaged) at ~39.7cm and bent at ~80.3cm from the proximal tip.The axium prime implant coil was found to be detached and not returned.The coin was found to be retracted from the lumen stop.No other anomalies were observed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil stretched¿ was unable to be confirmed, as no implant coil was returned for assessment.No possible cause for the coil stretching was able to be determined.Regarding the pushwire kink/damage, is it possible the damage may have occurred from advancement against resistance.A possible cause for the resistance is but not limited to, tortuous anatomy, and/or damage or kink to pushwire.The axium prime implant coil was not returned for assessment; therefore, the condition of the implant coil was unable to be analyzed.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that an axium coil was stretched.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm located on the c6 segment of the internal carotid artery, with a max diameter of 4mm and a 1.6mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that intraoperatively, the coil became stretched; another coil was used instead, and the procedure was completed successfully.All devices were prepared as indicated in the ifu and no patient complications were associated with this event.Additional information was received.No issues were identified that resulted in the damage observed.The cause of the resistance was not determined and remains unknown.

• 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: 25562426
• Report Number: 9617601-2026-03869
• Device Sequence Number: 10012502
• Product Code: KRD
• UDI-Device Identifier: 00763000313616
• UDI-Public: (01)00763000313616(17)280328(10)230911563
• 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
• Report Date (Section B): 06/19/2026

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: 230911563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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 Age: 58 YR
• Patient Sex: Female