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

Model Number	APB-1-4-3D-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a detachable coil apb-3-8-3d-es was delivered using an echelon 10 microcatheter.The coil did not form a hoop well within the aneurysm; the operator noted that the middle segment was straight and unshaped, so it was withdrawn and discarded.The operator then replaced the first coil with an apb-3-6-3d-es coil for embolization.After complete filling, the coil was kinked and withdrawn, and detachment was attempted with the detachment wire, but the coil was not detached.The entire coil was retrieved, and the same model coil was used to continue the procedure.As the final coil for embolization, under continuous drip infusion, pushing the coil through the echelon 10 microcatheter was very difficult and resistant.The catheter was withdrawn, and upon removal, it was found that the coil had already been stretched, was not implanted, and the treatment was concluded.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).It was unknown if any patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a saccular, unruptured right middle cerebral artery bifurcation aneurysm with a max diameter of 4.74mm by 3.91mm and a3.07mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.
Additional Manufacturer Narrative
H3 product analysis: as found condition (condition of returned device): two axium prime coils were returned for analysis within a shipping box; within a sealed biohazard pouch; within their opened axium prime coil inner pouches.The echelon-10 micro catheter used during the event was not returned.Visual inspection/damage location details: (pli-10) the axium prime coil was returned within its introducer sheath.The axium prime coil pushwire was found to be bent at ~71.4cm.The implant coil appeared to be stretched and damaged within the introducer sheath.The axium prime coil was pushed out further from the introducer sheath for additional evaluation.The implant coil was found to be stretched and damaged.No other anomalies were observed.(pli-30) the axium prime coil was returned with introducer sheath.The axium prime coil pushwire was found to be broken but retained by release wire at ~153.1cm from proximal end.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): (pli-30) the axium prime coil could not be used for resistance testing with in-house micro catheter due to its damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil shape-loop size¿ could not be confirmed.However, the implant coil was found to be damaged.It is likely the damage to the implant coil contributed to the customers report for pli-10.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ for pli-30 could not be confirmed as the axium prime coil could not be used for resistance testing with in-house micro catheter due to its 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 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 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 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: 24747467
• Report Number: 9617601-2026-02165
• Device Sequence Number: 12956779
• Product Code: KRD
• UDI-Device Identifier: 00763000313630
• UDI-Public: (01)00763000313630(17)280328(10)230911575
• 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
• Report Date (Section B): 05/14/2026

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-1-4-3D-ES
• Device Catalogue Number: APB-1-4-3D-ES
• Device Lot Number: 230911575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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: Female