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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): the axium prime coil was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The axium prime coil was returned without the introducer sheath.Visual inspection/damage location details: the axium prime pushwire was found to be kinked at ~3.3cm from proximal end.The axium prime pushwire assembly and implant coil were not returned.The release wire appears to have been removed from pushwire assembly.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the implant coil was not returned.The root cause could not be determined.This event is reported at this time based on analysis findings which indicate possibility of a reportable device issue.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 during use.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the ophthalmic artery with a max diameter of 4mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information was received that there were no issues that resulted in the damage that was found.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 22866601
• Report Number: 9617601-2025-01111
• Device Sequence Number: 12675097
• Product Code: KRD
• UDI-Device Identifier: 00763000313838
• UDI-Public: (01)00763000313838(17)270702(10)229175970
• 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): 08/21/2025

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-1.5-3-HX-ES
• Device Catalogue Number: APB-1.5-3-HX-ES
• Device Lot Number: 229175970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 58 KG