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

Model Number	APB-2-4-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id apb-1.5-2-3d-es (229115240).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 two axium coils were prematurely detached.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the c7 segment with a max diameter of 3.3 mm and a 1.2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that during the aneurysm surgery, the coil was detached prematurely and did not completely embolized into aneurysm.After adjustment with a new coil and stent, the surgery was successfully completed.The reported device and any accessory devices were prepared as indicated in the instructions for use (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.
Event or Problem Description
Additional information received reported that no detachment attempts were made.There was no kink/damage observed on the pushwire.The coil was implanted, but was not in the intended location.No additional medical/surgical intervention was required as it was pressed with a stent to stick it to the wall.Two coils had been implanted before and after the coil malfunctioned.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened axium prime inner pouch and within a dispenser coil.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.No evidence of detachment attempt using an instant detacher was found at this location.The pusher was found kinked at ~3.6cm from the proximal end (figure l).The pusher was found broken at ~5.4cm from the proximal end (between the positive load indicator and break indicator (figure m), indicative of a potential manual detachment attempt.The release wire was found fully retracted out of the pusher (figure n).The coin was found damaged and stuck within a portion of the coupler tube.The pusher was found kinked at ~31.2cm from the distal end of the distal pusher segment.The coin was found fully retracted out of the lumen stop.The shield coil was found damaged (figure q).The implant coil was already detached and not returned for analysis.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was confirmed as the implant was already detached.The cause of the detachment was due to the pusher break and release wire retracted out of the lumen stop, detaching the implant as expected by the detachment subassembly.Customer reported no detachment attempts were made and no kink/damage observed with the pusher.However, the pusher was found kinked/broken.In addition, the shield coil was found damaged, potentially due to advancing/retracting against resistance.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: 21434375
• Report Number: 9617601-2025-00202
• Device Sequence Number: 19917721
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: 00763000313692
• 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,Followup
• Report Date (Section B): 05/01/2025

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 229477270
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 02/24/2025; 04/19/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/18/2025; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male