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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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.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
It was reported that during the treatment of a ruptured ophthalmic aneurysm with amorphous morphology (maximum diameter 5.5 mm, neck diameter 3.7 mm), high blood flow and severe vessel tortuosity were present.The procedure involved the use of axium prime bare hx 2mm x 8cm extra and axium prime bare 3d 2.5mm x 6cm extra coils.The left internal carotid artery was accessed using an sl-10 microcatheter and synchro guidewire.The first two coils were deployed smoothly.When the third coil (3d 2.5x6) was advanced, resistance was encountered during delivery in the middle of the catheter, and upon removal, the coil was found to be stretched.The damage was at the pushwire middle segment.The physician did not reposition the coil during the procedure.The next coil (hx 2x8) was deployed and detached without issue.During deployment of a subsequent coil (hx 2x6), the wide neck of the aneurysm caused the last few loops and the previously placed coil (hx 2x8) to migrate into the middle cerebral artery segment.The hx 2x6 coil was retracted and removed, and the migrated hx 2x8 coil was also removed using a phenom 27 and sfr x 6x40.The devices were prepared according to the instructions for use (ifu).The procedure was completed with the placement of three additional coils.Images were available for review.No patient complications have been reported as a result of this event.Ancillary devices: sl-10 microcatheter, synchro guidewire, phenom 27 catheter, sfr x 6x40 stent.
Event or Problem Description
Additional information was received.The hx 2x6 coil used was an optima helical 2x6 coil, and no antiplatelet regimen was given to the patient.
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.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime implant coil was returned for analysis within a shipping box, within an opened axium prime outer carton, within an opened axium prime inner pouch and within a piece of surgical wrap.A second axium prime device was also returned and will be addressed in pli-20.Visual inspection/damage location details: the axium prime implant coil was found stretched/damaged/broken with the polypropylene filament broken.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil migration after deployment¿ cannot be confirmed through device analysis.Possible causes are high blood flow, coil loop in parent vessel, or coil incorrectly sized to vessel.Customer reported vessel tortuosity as severe, continuous flush was administered and maintained per ifu.It is possible the severe tortuosity contributed towards the coil migration.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
Additional information was received.A continuous saline flush was administered and maintained as indicated in the ifu.The3d 2.5x6 coil come out of the introducer sheath smoothly.It was noted that after removal, the catheter was not damaged.
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.

• 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: 22689116
• Report Number: 9617601-2025-00775
• Device Sequence Number: 12824722
• Product Code: KRD
• UDI-Device Identifier: 00763000313906
• UDI-Public: (01)00763000313906(17)271007(10)229795539
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 09/22/2025

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-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 229795539
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/22/2025; 09/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/14/2025; 09/02/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 81 KG