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

Model Number	APB-2-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an echelon 10 microcatheter was advanced to the lesion site.When the axium prime bare hx coil was delivered to the proximal part of the microcatheter, resistance was encountered and it became stuck inside the microcatheter hub, unable to be advanced or withdrawn.It was noted that the implant coil had pushed smoothly out from the introducer sheath.The microcatheter and coil were withdrawn together and were replaced with non-medtronic products to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a ruptured, saccular, anterior communicating artery aneurysm with a max diameter of 2 mm and a 1.3 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.Femoral artery access vessel diameter was 10 mm.The angiographic result post procedure showed dense embolization.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Ancillary devices included sl10 microcatheter and a microport coil.
Additional Manufacturer Narrative
Continuation of d10: echelon 10 microcatheter product id 145-5091-150 (lot 0227926535).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
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
Additional information was received stating that the cause of the resistance and inability to resheath the coil was not determined.A continuous saline flush was administered and maintained as indicated in the ifu.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): an axium implant coil and an echelon-10 micro catheter were returned for analysis within a shipping box and within a sealed biohazard pouch.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: (pli-10) the axium implant coil pushwire was found to be broken and separated distal to break indicator.Total length of separated broken proximal end was measured to be ~7.9cm.The axium prime coil was found to be broken and not returned.No other anomalies were observed.(pli-20) the echelon-10 total length was measured to be ~155.7cm.The echelon-10 useable length was measured to be ~147.8cm which is within specification.Upon visual examination, no issues were found with the echelon-10 hub or catheter body.The distal marker band was found to be flattened.The distal tip was noted to be pre-shaped.No other anomalies were observed.Testing/analysis (including sem reports): (pli-10) the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.(pli-20) the echelon-10 micro catheter was flushed, water exited from the distal tip.One in-house axium implant coil was able to enter and pass through the echelon-10 micro catheter hub without issue.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ could not be confirmed.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, failure to use a compatible microcatheter for delivery, and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).Improper hubbing technique could not be ruled out as a potential root cause for the event.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance at hub¿ could not be confirmed, and the root cause could not be determined.No damages were found with the returned echelon-10 micro catheter that would have contributed to the reported resistance.In addition, an in-house axium implant coil was able to enter and pass through the echelon hub without issue.Possible contributing factor to ¿catheter resistance at hub¿ is ancillary device damage.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium implant coil instructions for use (ifu): ¿axium implant detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium implant coil and can be ruled out as a potential cause.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: 23535088
• Report Number: 9617601-2025-02680
• Device Sequence Number: 10186729
• Product Code: KRD
• UDI-Device Identifier: 00763000313883
• UDI-Public: (01)00763000313883(17)270801(10)229294003
• 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): 01/26/2026

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-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 229294003
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/07/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 73 YR
• Patient Sex: Male