MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-4-3D-ES
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #707029397:equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within a seal plastic biohazard pouch; within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the proximal axium prime pusher was found not within its black guidewire clip (figure c).The axium prime pusher was found broken at ~3.2cm from the proximal end with the two segments retained by the release wire.The introducer sheath was found correctly assembled on the pusher with the wavelock at the proximal end.No damages or irregularities were found with the introducer sheath.No other damages or irregularities were found with the remaining axium prime pusher.The implant coil was found already detached from the pusher (figure e).No damages were observed with the implant coil.The coin was already retracted out of the lumen stop.No other anomalies were observed.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil separation/break¿ was confirmed.The pusher was found broken, with the release wire/coin retracted out of the lumen stop, detaching the implant coil as designed by the detachment elements.Customer reported the pusher was found secure within the black guidewire clip and no damages/breaks were found with the pushwire; which was not confirmed during analysis.Therefore, the cause of the pusher break could not be determined.It is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.The root cause could not be determined.There is an indication that this could potentially be caused by a potential manufacturing issue and a dhr review is required.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
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 information that an axium coil was broken out of box.After opening the coil package, the distal end of the coil was found to be broken and couldn't be used, so the surgeon requested a return.The pushiwre was not bent or broken.Continuous flush was administered during the procedure.The devices were prepared according to the instructions for use (ifu).The patient was being treated for an unruptured, saccular aneurysm in the left internal carotid artery communicating segment.The max diameter was 5mm and the neck diameter was 3mm.Patient blood flow and vessel tortuosity was normal.No patient injury or symptoms were reported.
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
Additional information received reported that there was no damage or evidence of tampering to device packaging.The damage was already found when removed from the packaging.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.Distal part of the coil was broken.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20317028
• Report Number: 9617601-2024-00210
• Device Sequence Number: 7679165
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: 00763000313692
• 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): 12/09/2024

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 Expiration Date: 07/01/2026
• Device Model Number: APB-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 226870663
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 09/29/2024; 11/14/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/22/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: 61 YR
• Patient Sex: Female