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	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium spring coil could not be detached.After replacing it with another es spring coil, it functioned normally.It was reported non-detachment occurred.The physician attempted to detach the coil with the instant detacher 0 times.The physician did not try to detach the coil with another instant detacher.There was one manual attempt made at detachment via hypotube.There was no issue with the instant detacher.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was noted the patient's blood flow was normal and vessel tortuosity was minimal.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
Product analysis as found condition- the axium prime pusher was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Visual inspection/damage location details - the axium prime pusher was found broken at the break indicator.The proximal segment was not returned for analysis.The release wire and coin were fully retracted out of the pusher/lumen stop and not returned for analysis.No damages or irregularities were found with the shield coil.The implant coil was already detached and not returned for analysis.The lumen stop was found undamaged.The retainer ring was found undamaged.Dried blood was found under the ptfe shrink tubing and within the lumen stop and retainer ring.Testing/analysis ¿ the coin could not be measured as it was not returned.The lumen stop inner diameter was measured to be 0.0029¿, which is still within specification (specification: 0.00220¿ ¿ 0.0029¿).Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the axium prime was returned with the implant already detached.The release wire was fully retracted, and the implant coil was already detached as expected by the detachment subassemblies.In addition, no damages or non-conformances to specification were found that would contribute towards the reported non-detachment.As the implant coil was not returned for analysis, any contribution of the implant towards the reported non-detachment could not be determined.Dried blood was found under the shrink tubing and within the lumen stop, potentially contributing towards non-detachment during the procedure; however, it is not known how much the blood had coagulated during the procedure.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
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 stating that the lesion was characterized as an unruptured, saccular aneurysm located in the anterior circulation at the c5-c6 segment, measuring 5mm by 4mm.The cause of the coil non-detachment was not determined.No issues were encountered prior to the coil non-detachment, and no pushwire damage was observed after removal from the patient.

• 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: 23631665
• Report Number: 9617601-2025-02949
• Device Sequence Number: 18737082
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: (01)00763000313739(17)280130(10)230574179
• 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): 01/28/2026

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-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 230574179
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 01/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG