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

Model Number	APB-1.5-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
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.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 coil was "unable to removed".The product was replaced with a medtronic coil to complete the procedure.No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an unruptured, saccular, c7 aneurysm with a max diameter of 1.5 mm and a 1.0 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).
Event or Problem Description
Additional information received reported clarification that the coil was not able to be pushed out of the distal end of the microcatheter.The coil had pushed out smoothly from the microcatheter.It was noted that continuous catheter flush was administered during the procedure.There was no kink or other damage observed to the catheter after removal.Based on additional information received, the event no longer a reportable event.Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates a reportable event.
Additional Manufacturer Narrative
Based on additional information received, the event no longer a reportable event.Mdr decision corrected to not reportable.No ad ditional supplemental reports are required unless additional information received indicates a reportable event.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 was returned for analysis within a shipping box; within a sealed biohazard pouch; within an opened axium prime coil inner pouch.The axium prime coil was returned within introducer sheath.The unknown micro catheter used during the event was not returned.Visual inspection/damage location details: no bends or kinks were found with the axium prime coil pushwire.The implant coil appeared to be damaged within the introducer sheath.The axium implant coil was pushed out further from the introducer sheath for additional evaluation.The axium prime coil was found to be stretched and damaged.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 coils could not be used for resistance testing with the returned micro catheter due to their damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.The model and lot numbers for the unknown micro catheter used during the event were not provided; therefore, 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.

• 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: 23074196
• Report Number: 9617601-2025-01481
• Device Sequence Number: 13261186
• Product Code: KRD
• UDI-Device Identifier: 00763000313845
• UDI-Public: (01)00763000313845(17)280111(10)230393724
• 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): 11/17/2025

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-1.5-4-HX-ES
• Device Catalogue Number: APB-1.5-4-HX-ES
• Device Lot Number: 230393724
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/27/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/17/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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: Unknown