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

Model Number	APB-3.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis; as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a sealed biohazard pouch and within a dispenser track.The echelon-10 micro catheter used during the event was not returned.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the axium prime coil pushwire was found to be kinked at ~1.1cm and broken but retained by release wire at ~3.3cm from proximal end.The implant coil was found to be already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium implant coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium prime coil instructions for use (ifu): ¿axium prime coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿- 0.017¿ with two marker bands.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium prime coils.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that after access was established, a 4-8 coil was filled in the aneurysm using an echelon microcatheter.A second coil, axium prime bare 3d, was delivered halfway into the microcatheter and could not be advanced further.It was noted that the coil was stuck at the catheter hub.The coil was replaced with a new coil of the same model to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing coil embolization surgery for treatment of a ruptured, saccular, posterior communicating artery aneurysm with a max diameter of 5 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The implant coil pushed smoothly out from the introducer sheath and there was no catheter or coil damage.Additional information was received.Coil resistance was encountered in the middle of the catheter.Continuous catheter flush was administered during the procedure.The cause of the resistance was not determined; however, the customer tended to believe that the product had quality issues, as replacement with another coil resulted in smooth delivery.

• 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: 23649543
• Report Number: 9617601-2025-03011
• Device Sequence Number: 15959334
• Product Code: KRD
• UDI-Device Identifier: 00847536021259
• UDI-Public: (01)00847536021259(17)270102(10)228012932
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203432
• 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): 11/25/2025

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-3.5-6-3D-ES
• Device Catalogue Number: APB-3.5-6-3D-ES
• Device Lot Number: 228012932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG