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

Model Number	APB-5-10-3D-SS
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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
Medtronic received a report that an axium coil would not detach.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).This product was used in the first case of cerebral aneurysm (lt.Ica-paraclinoid), but it could not be detached even after using id-1-5 (b628329), followed by forced detachment in two places.The delivery wire was pushed and pulled several times to detach.There were no patient symptoms or complications associated with this event.
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 was received reporting the cause of the detachment issue was not determined.More than 3 attempts were made to detach the coil using the instant detacher.2 attempts were made to detach the coil using the manual method.No pushwire damage was observed after removal from the patient.Prior to the coil non-detachment no issues were encountered.
Additional Manufacturer Narrative
Product analysis (b)(4) :equipment used- video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition- the axium prime device was returned for analysis within a shipping box and within a resealable plastic biohazard pouch.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found loose within the coupler tube.This is indicative of a detachment attempt using an instant detacher at this location.The pusher was found broken at the positive load indicator with the release wire broken at the same location.The break indicator was also found broken, with the two segments retained by the release wire.It is likely that a manual detachment was attempted at these locations.No other damages were found with the axium prime pusher.The coin was found fully retracted out of the lumen stop.Blood was found under the ptfe shrink tubing, within the lumen stop, within the retainer ring and on the coin.No damages or irregularities were found with the shield coil.The implant coil was already detached and not returned for analysis.Testing/analysis ¿ the exposed release wire was retracted, and the release wire was found stuck.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved.The release wire was again retracted and moved freely.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was not confirmed as the implant was already detached and not returned; however, it could not be ruled out.It is possible the cause of the non-detachment is the blood found within the lumen stop and under the jacket causing the release wire to not retract freely.The release wire moved freely with no issues once the blood was dissolved during analysis.There were no damages found with the returned device that would cause the reported non-detachment.As the instant detacher used during the event was not returned for analysis, any contribution of the instant detacher to the non-detachment could not be assessed.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.

• 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 CA 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19055132
• Report Number: 2029214-2024-00585
• Device Sequence Number: 8188182
• Product Code: KRD
• UDI-Device Identifier: 00847536008182
• UDI-Public: 00847536008182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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: 02/21/2025
• Device Model Number: APB-5-10-3D-SS
• Device Catalogue Number: APB-5-10-3D-SS
• Device Lot Number: 223839670
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 05/10/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/01/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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 Sex: Unknown