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

Model Number	APB-2.5-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
Type of Reportable Event	Malfunction
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
Medtronic received a report that the axium coil encountered resistance and was stuck in middle section of the echelon catheter.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm with a max diameter of 3 mm and a 1.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.The access vessel was the femoral artery with 8mm diameter.It was reported that the physician conducted a procedure for an anterior communicating artery aneurysm.After puncture, an intermediate catheter and an echelon10 microcatheter were positioned at the lesion site.The first coil, apb-3-6-3d-es (batch number 229175214), was hydrated and successfully deployed within the aneurysm.For the second coil, apb-2.5-4-hx- es (batch number :228012936), significant resistance was encountered midway through the microcatheter, preventing further advancement.The surgeon carefully attempted to retract the coil, but it was stuck inside the microcatheter and could not be retrieved.Both the microcatheter and the second coil were removed together.It was unclear whether the issue was due to the microcatheter or the second coil.A new echelon10 catheter was then used.A third coil, apb-2-4-hx-es (batch number 229655963) was successfully advanced and detached, followed by the successful implantation and detachment of the fourth coil, apb-1.5-3-hx-es.Angiography showed dense packing of the aneurysm, and the patient's condition remained stable, concluding the surgery.It was unknown if the catheter and the second coil were damaged.The reported devices and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Event or Problem Description
Additional information received reported the coil came out of the introducer sheath smoothly.There was no kink or other damage observed to the catheter or coils.The cause was not determined.
Additional Manufacturer Narrative
B5: updated with additional information received.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 (condition of returned device): an axium prime coil and an echelon-10 micro catheter were returned for analysis within a shipping box and within a sealed biohazard pouch.The axium prime coil was returned without the introducer sheath.Visual inspection/damage location details: the axium prime coil pushwire was found to be broken at load indicator, kinked at ~46.0cm, broken and separated at ~133.4cm from broken proximal end.The axium prime 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 returned echelon-10 micro catheter due to their damaged condition.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: 22021263
• Report Number: 9617601-2025-00466
• Device Sequence Number: 8769891
• Product Code: KRD
• UDI-Device Identifier: 00763000313920
• UDI-Public: (01)00763000313920(17)270104(10)228012936
• 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,Followup,Followup
• Report Date (Section B): 07/05/2025

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-2.5-4-HX-ES
• Device Catalogue Number: APB-2.5-4-HX-ES
• Device Lot Number: 228012936
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/13/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 58 YR
• Patient Sex: Female