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 Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, an opened axium prime inner pouch, within a dispenser coil, and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found to be applied incorrectly with the wavelock facing towards the distal end of the implant coil.The pushwire was found to be bent/kinked at ~1.7cm, at ~4.1cm, and bent/kinked at ~32.4cm from the proximal end; in addition, the pushwire was found to be broken at the 3 tack welds distal to the break indicator coupler tube.The axium prime implant coil was found to be detached from the pushwire and not returned.The shield coil was found to be damaged, and the coin was retracted from the lumen stop.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damaged/deformed out of pkg¿ was unable to be confirmed.The axium prime device was returned with excessive damage.A possible cause of the reported damage could have occurred upon opening the package and attempting to remove the product, and/or improper handling of the device.A few possible causes of ¿prod damage/deformed out of pkg¿ are but not limited to, impact from an unknown source prior to being opened, damaged during storage, user-related, and mfg-related (e.G., operator handling damage, missed inspection); however, the root cause was unable to be determined.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu), in addition, updated information was received stating ¿it was not confirmed if any preparation was performed prior to the damage being seen.¿.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink/damage¿ was able to be confirmed, as the axium prime device was returned damage with the pushwire bent/ broken, which can possibly lead to the release wire being pulled and the axium prime implant coil detaching prematurely from the pushwire.A possible causes of ¿coil kink/damage¿ is but not limited to advancing device against resistance, and or damaged during preparation.The root cause was unable to de determined.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 an axium prime bare 3d coil pusher was observed to be kinked upon opening.The patient was undergoing surgery for treatment of an unruptured, saccular, ophthalmic artery aneurysm with a max diameter of 3 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Continuous flush was administered during the procedure.When the coil package was opened, it was found that the spring coil push rod was kinked.In vitro examination revealed that the spring coil was damaged, so another product of the same model was used to continue the surgery.There was no friction or difficulty during testing or delivery.There was no patient involvement.Additional information was received stating that there was no damage or evidence of tampering to device packaging.It was not confirmed if any preparation was performed prior to the damage being seen.There were no issues that resulted in the device damage that was found.The cause of the kink was not determined.

• 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: 23413949
• Report Number: 9617601-2025-02341
• Device Sequence Number: 21434561
• Product Code: KRD
• UDI-Device Identifier: 00763000313616
• UDI-Public: (01)00763000313616(17)270728(10)229294001
• 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): 10/29/2025

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: 229294001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 49 KG