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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 coil embolization for an unruptured right middle cerebral artery aneurysm with amorphous morphology, the axium prime bare hx 1.5mm x 3mm extra coil failed to detach after placement in the aneurysm.An instant detacher was not used.A manual detachment attempt was made, and the coil was carefully removed.Upon inspection outside the body, the coil detached.The coil was replaced with a new one, and the procedure was successfully completed.The aneurysm max diameter was 3mm and the neck diamteter was 2mm.Patient blood flow was normal and vessel tortusoity was moderate.No patient complications have been reported as a result of this event.Ancillary devices: echelon lot: 0230380653.
Event or Problem Description
Additional information was received.No kink/damage was observed on the pushwire.The coil did not detach from the catheter during removal , and there were no issues encountered before coil's non-detachment.
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 was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an opened axium prime inner pouch.Visual inspection/damage location details: the axium prime pusher was found broken at the positive load indicator and the break indicator with the release wire retracted (figure c).The release wire was entangled with the returned pusher (figure d).The pusher was found bent at ~36.1cm from the proximal end (figure e).The coin was found fully retracted out of the lumen stop (figure f).The shield coil was found undamaged.The implant coil was already detached.The retainer ring was found damaged (figure g).Blood was found within the retainer ring.The lumen stop was found damaged (ovalized) (figure h).The coin was found undamaged.The implant coil was found undamaged.The implant was stretched to find the detach element, however, the detach element was missing due to the polypropylene filament found broken (figure k).Testing/analysis ¿ the coin was measured to be ~0.088mm @ 0.063mm, ~0.098mm @ 0.127mm, and ~0.099mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).The retainer ring and lumen stop inner diameters could not be reliably measured due to the damaged conditions.The detach element ball outer diameter could not be measured as it was separated from the implant coil and not returned for analysis.Conclusion - based on the customer report and device analysis, the customer report of "premature detach.From a non-detach" could not be ruled out.The lumen stop was found damaged, indicative that the coin potentially was jammed/stuck within the lumen stop, preventing the release wire from retracting.The retainer ring was found damaged and the detach element was found separated, potentially detaching the implant after the device was reported removed from the patient.The likely cause could not be determined.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: 22562410
• Report Number: 9617601-2025-00669
• Device Sequence Number: 14429289
• Product Code: KRD
• UDI-Device Identifier: 00763000313838
• UDI-Public: (01)00763000313838(17)280118(10)230462863
• 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): 10/02/2025

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-1.5-3-HX-ES
• Device Catalogue Number: APB-1.5-3-HX-ES
• Device Lot Number: 230462863
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 09/16/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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 Age: 56 YR
• Patient Sex: Male