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

Model Number	APB-3-6-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
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 an aneurysm embolization procedure to treat an unruptured saccular aneurysm in the posterior communicating artery, after the axium prime bare 3d 3mm x 6cm extra soft spring coil was pushed and detached, the push rod was withdrawn and the spring coil was found to be pulled out of the aneurysm.The spring coil was not detached successfully and was separated only after repeatedly pushing the push rod.The aneurysm had a maximum diameter of 5 millimeters and a neck diameter of 3.6 millimeters.The patient's blood flow and vessel tortuosity were normal.The devices were prepared according to the instructions for use (ifu).No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
H3: product analysis of apb-3-6-3d-es, lot no.: 229115235.As found condition- the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and within an unknown introducer sheath.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found unbroken.There is no evidence of detachment attempts using an instant detacher or by manual method at these locations.The pusher was found kinked at ~139.1cm from the proximal end.The coin was found still against the lumen stop.Blood was found within the retainer ring.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found to be severely stretched and damaged with the polypropylene filament broken.The implant coil was found unbroken (tip still attached to the implant.Testing/analysis ¿ the break indicator was broken, and the release wire was found stuck when retracted, the coin broke during the detachment attempt.As the coin became broken, the release wire could not be retracted after the blood was dissolved.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is possible the cause of the non-detachment is the blood found within the retainer ring, causing the coin to become stuck within the lumen stop.Customer reported attempting two manual detachment attempts, however, the pusher was found unbroken along the length of the entire pusher.Therefore, the event could not be confirmed.The implant was found stretched/damaged.It is likely the retraction of the pusher after the non-detachment caused the implant to retract out with the pusher, causing the implant to become damaged if it became entangled with other coils within the device.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
Additional information received reported that an instant detacher was not used.Two manual detachment attempts had been made.There were no issues prior to non-detachment, and no pushwire damage was observed.
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 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: 21509634
• Report Number: 9617601-2025-00219
• Device Sequence Number: 20838363
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: 00763000313739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/15/2025

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-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 229115235
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 05/02/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/31/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2024
• 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: 72 YR
• Patient Sex: Male