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

Model Number	APB-1-1-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding axium coil non-detachment.The patient was undergoing a coil embolization procedure to treat a right vertebral artery v1 segment unruptured saccular aneurysm.The aneurysm max diameter was 13mm and the aneurysm neck diameter was 10mm.Patient's blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil and any accessory device used were prepared according to the instructions for use (ifu).Two attempts were made with the instant detacher, but the coil failed to detach.Another instant detacher was not tried and the site indicated there was not a problem with the instant detacher.Two further attempts were made at detachment using manual method/hypotube, but the coil still failed to detach.Therefore, the coil was removed and replaced to complete the procedure successfully.There was no harm or injury to the patient associated with 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 was received.The cause of the non-detachment was not determined.The instant detacher was not used.Prior to the coil non-detachment, no issues were encountered.No pushwire damage was observed after removal from the patient.
Additional Manufacturer Narrative
¿ updated b5, d9 ¿ h3: analysis results were not available at the time of this report.A follow-up will be sent once analysis is complete.H6: the evaluation codes have been updated for this event 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 an unsealed plastic biohazard pouch.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details ¿ the actuator interface was found securely attached to the coupler tube.The pusher was found broken between the positive load indicator and break indicator, with the release wire retracted.The release wire and coin were retracted out of the pusher/lumen stop.The axium prime pusher was found with multiple bends throughout the length of the pusher.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 damaged.The retainer ring was found damaged.Dried blood was found under the ptfe shrink tubing and within the lumen stop and retainer ring.Testing/analysis ¿ ¿ the coin was measured to be ~0.089mm @ 0.063mm, ~0.097mm @ 0.127mm, and ~0.099mm @ 0.275mm, which is within spe cification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).The lumen stop and retainer ring inner diameter could not be measured due to the damages.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was likely to have occurred.The lumen stop was found damaged, indicative that the coin was potentially jammed within the inner diameter of the lumen stop, preventing the implant from detaching.The cause of the coin stuck within lumen stop could not be determined.There was no non-conformance to specifications that would contribute towards the stuck coin and subsequent non-detachment.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 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: 23680241
• Report Number: 9617601-2025-03082
• Device Sequence Number: 9846888
• Product Code: KRD
• UDI-Device Identifier: 00763000313784
• UDI-Public: (01)00763000313784(17)280306(10)230743949
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/04/2026

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-1-1-HX-ES
• Device Catalogue Number: APB-1-1-HX-ES
• Device Lot Number: 230743949
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/28/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/25/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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: 49 YR
• Patient Sex: Male