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

Model Number	APB-1-2-3D-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the axium prime device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the axium prime pusher was found broken between the positive load indicator and the break indicator with the release wire retracted.The coin was found fully retracted out of the lumen stop, the shield coil was found undamaged, and the implant coil was already detached and not returned for analysis.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ could not be confirmed as the implant was already detached.The pusher was broken, the release wire was retracted, and the implant coil was detached as expected by the detachment subassemblies.Customer did not report detaching the device.Possible causes of coil stretching during the procedure are, lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance, damaged micro catheter, or incompatible catheter.Customer reported vessel tortuosity as normal, and devices were prepared per ifu.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the reported coil stretching could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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 report that during the delivery of the axium coil, it was noted that the tip of the coil was stretched.It was noted that the axium coil and all accessory devices had been prepared per the instructions for use (ifu).The coil was removed and replaced to continue to the procedure.There was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a c6 segment unruptured saccular aneurysm.The aneurysm max diameter was 3.2mm and the neck was 3.1mm.Blood flow and vessel tortuosity were normal.Additional information was received stating that no issues resulted in the damage that was found.

• 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: 22669021
• Report Number: 9617601-2025-00752
• Device Sequence Number: 11688000
• Product Code: KRD
• UDI-Device Identifier: 00763000313616
• UDI-Public: (01)00763000313616(17)270705(10)229175909
• 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
• Report Date (Section B): 07/30/2025

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-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: 229175909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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