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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: instant detacher, product id: unk-nv-ap-id (lot: unknown).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 an axium prime bare hx coil did not detach.The patient was undergoing coil embolization surgery for an emergent takedown of an oropharyngeal bleed at the level of the right superior thyroid.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.The coil was the 4th axium coil to be introduced for embolization to the takedown of the oropharyngeal artery, with other axium coils prior detaching without issue.After three failed attempts to detach the coil using the instant detacher, slight retraction of the microcatheter was performed to see if that would help detach, however, this attempt was unsuccessful.One manually detachment was then attempted at the manual break point on the coil pusher wire, but this attempt was also unsuccessful.Without issue, the coil was fully removed and replaced with another coil of the same model and lot, detaching without issue.The oropharyngeal artery embolization was successfully embolized without patient complications with a total of eleven axium coils.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).All axium coils were prepped per fda guidelines and hydrated in a blue plastic bowl of saline vertically.No attempts were made to detach with another instant detacher.It was reported that there was no issue with the instant detacher.The same medtronic coil detacher was used to detach all eleven axium coils during the procedure.Ancillary devices included cerenovus 5f mpc guide 90cm (ref#: (b)(4), lot#: 31763920), stryker excelsior sl-10 microcatheter straight tip (ref#: (b)(4), lot#: 26061542.

• 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: 24985604
• Report Number: 9617601-2026-02701
• Device Sequence Number: 9480868
• Product Code: KRD
• UDI-Device Identifier: 00847536021020
• UDI-Public: (01)00847536021020(17)270830(10)229583298
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 229583298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 08/30/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 61 KG