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

Model Number	APB-3.5-10-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): both axium prime device were returned for analysis within a shipping box, within individual opened outer cartons (lot- 230562491 and lot-226786515), and with pli-10 returned within an opened axium prime inner pouch (lot- 230562491).No introducer sheath was included.Visual inspection/damage location details: no introducer sheath was returned.The pushwire was found to be broken, with the release wire full retracted out of the pushwire coupler tube.The axium prime implant coil was found to be detached and not retuned.The coin was found to be retraced from the lumen stop.No anomalies were observed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed; however, the event could not be ruled out.No introducer sheath was returned for assessment.Any contribution the introducer sheath had towards the damage was unable to be assessed.A few possible causes of ¿coil resistance/stuck in sheath¿ are, but not limited to, damage during preparation, overtightening of rhv, incompatible devices, inverted sheath, and/or improper hubbing technique; however, the root cause for the resistance was unable to be determined.It is possible the damage may have occurred during preparation, as no report of any issues or irregularities were observed or noted prior to preparation.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu); in addition, a continuous saline flush was administered as indicated in the ifu.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 encountered resistance/were stuck in the sheath.It was reported that there was a gritty feel while pushing 1-2cm of the coils inside the plastic sheath introducer.The coils did not come out of the sheaths smoothly.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient was involved in the event.Additional information received reported that the contributing factor of the resistance was that the device was stuck on the plastic coil introducer.Additionally, continuous saline flush was administered as indicated in the ifu and during preparation the introducer sheath was laid horizontality flat in the table.All information was confirmed by the physician.

• Brand Name: AXIUM PRIME BARE PL 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: 25411448
• Report Number: 9617601-2026-03601
• Device Sequence Number: 9614095
• Product Code: KRD
• UDI-Device Identifier: 00763000313777
• UDI-Public: (01)00763000313777(17)280127(10)230562491
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 06/05/2026

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-3.5-10-3D-ES
• Device Catalogue Number: APB-3.5-10-3D-ES
• Device Lot Number: 230562491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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 Sex: Unknown