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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the spring coil could not be detached.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.
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.
Additional Manufacturer Narrative
Supplemental was sent to update b5, d9, g3, h2, h6.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.The procedure involved embolization of a c6 segment aneurysm, with the vessel noted to have normal tortuosity.The patient was reported to be recovering well and experienced no symptoms related to the coil non-detachment.No pr ocedural or post-procedural imaging was available for review.Attempts to resolve the non-detachment included using an electric detachment method, which was unsuccessful.The procedure was ultimately completed by replacing the spring coil with another one.The cause of the non-detachment could not be determined.A total of five attempts were made to detach the coil using the instant detacher and six attempts were made using the manual method.No issues were reported prior to the coil non-detachment, and no pushwire damage was observed after removal from the patient.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- vis m-81805 203cm ruler m-83360 as found condition-the axium prime device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, and within an opened axium prime inner pouch.Visual inspection/damage location details ¿ no introducer sheath was returned.The pushwire was found to be broken at the break indicator, with the actuator interface and the release wire both not returned; in addition, the pushwire was found to be bent at ~113.5cm, bent at 142.3cm, bent at ~144.1cm and broke at ~153.1cm from the broken proximal end.No implant coil was returned.No other anomalies were observed.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the axium prime implant was found broken off and not returned.The report notes ¿no pushwire damage was observed after removal from the patient¿.This was unable to be confirmed.The pushwire was returned broken and bent in multiple location, with no implant coil returned.The damage was likely caused by the multiple attempts to detach the implant coil.The report states ¿a total of five attempts were made to detach the coil using the instant detacher and six attempts were made using the manual method¿.No root cause was able to be determined.No issues were reported prior to the non-detachment of the coil.The device and any accessories were prepared as indicated in the ifu.H6.Coding updated based on analysis findings.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: 22730169
• Report Number: 9617601-2025-00841
• Device Sequence Number: 15695237
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: (01)00763000313739(17)270811(10)229409072
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 229409072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 09/26/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/09/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2024
• 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
• Patient Weight: 58 KG