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

Model Number	APB-1.5-3-3D-ES
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): the echelon-14 and both axium prime devices were returned for analysis within a shipping box, inside of opened individual outer cartons, opened individual inner pouches, and both axium prime devices within individual introducer sheaths.Damage location details: the introducer sheath was found to be applied correctly, with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was found to be bent at ~6.7cm and broken (release wire visible) at ~7.2cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath at ~13.4cm from the distal end.The axium prime implant coil was found to be intact with the pushwire detach element.The implant coil was found to be damaged within the introducer sheath.No other anomalies were observed.Testing/analysis (including sem reports): during testing, the axium prime implant coil was unable to advance outside of the introducer sheath.The axium prime implant coil tip outer diameter (od) was measured to be 0.0105¿, which was found to be within specification (specification.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured to be.018¿ (0.45mm), which was found to be within specification (specification 0.46mm ±0.02mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was able to be confirmed, as resistance was able to be reproduced with the introducer sheath during testing.A few possible causes of ¿coil resistance/stuck in sheath¿ are but not limited to, damage during preparation and/or overtightening of rhv; however, the root cause was unable to be determined.The report mentions that ¿it is not known whether the coil came out of the introducer sheath smoothly¿.It¿s likely the ¿stuck in sheath¿ occurred after the advancement against the resistance, as no damage or irregularities were mentioned prior to use (during preparation).Based on the device analysis and the reported information, the customer¿s report of ¿coil kink/damage¿ was able to be confirmed, as the implant coil was found to be damaged within the introducer sheath.The likely cause for ¿coil kink/damage¿ was determined to be caused by advancement against the reported resistance.The report mentions that ¿resistance was encountered in the hub passage of the catheter¿.Via the ifu the axium prime device was found to be compatible with the echelon-14 microcatheter.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu); in addition, a continuous saline flush was administered and maintained as indicated in the ifu.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 the patient was undergoing treatment for embolization cerebral.It was noted that the patient's vessel tortuosity was unknown. it was reported that the doctor experienced resistance of the echelon microcatheter in the passage of the axium coil springs, causing defects in them.The two coils were stuck in the sheath.Also the catheter resistance was encountered within the guide catheter during the procedure.It is unknown whether there was any damage to the guide catheter. the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The event led to extended patient hospitalization.No patient symptoms or complications were associated with this event.Additional information was received.The cause of the resistance was not determined.Resistance was encountered in the hub passage of the catheter.It is not known whether the coil came out of the introducer sheath smoothly.Continuous saline flush was administered and maintained as indicated in the ifu.No kink or damage was observed on either the coil or the catheter after removal.The guide catheter was not a medtronic product, and no kink or damage was found on the guide catheter.It is not known whether the introducer sheath was held vertically during hydration.
Additional Manufacturer Narrative
Update b5.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
The patient needed to be re-approached at another time where the procedure will be rescheduled.

• Brand Name: AXIUM PRIME BARE PL 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: 24329282
• Report Number: 9617601-2026-01182
• Device Sequence Number: 14680982
• Product Code: KRD
• UDI-Device Identifier: 00763000313654
• UDI-Public: (01)00763000313654(17)270925(10)229751353
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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-1.5-3-3D-ES
• Device Catalogue Number: APB-1.5-3-3D-ES
• Device Lot Number: 229751353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female