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

Model Number	QC-8-20-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 the coil was prematurely detached during the preparation and it was discarded.The reported device and any accessory devices were prepared as indicated in the ifu.The continuous flush administered during the procedure.There was no surgical or medicinal intervention required and no patient symptoms were reported.
Additional Manufacturer Narrative
H3: product analysis #813920068:equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box and within a sealed tyvek biohazard pouch.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium pushwire was found to be kinked at ~6.1cm from proximal end.The axium coil pushwire was found to be broken but retained by release wire at break indicator.The coin was found to be not against the lumen stop.The implant coil was already detached and not returned.No other anomalies were observed.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium implant coil was returned with the implant already detached; however, the root cause could not be determined.It is likely the premature detachment was due to the pushwire break at break indicator causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon opening the package and attempting to remove the product or after removing it from the package and preparing it per ifu.The customer reported preparation was completed to the coil prior to detaching the implant coil prematurely.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 the cause of the detachment was not determined.It was unknown if any detachment attempts (instant detacher or manual method) were made.It was unknown if there was any kink/damage observed on the pushwire.The coil was implanted in the intended location.
Additional Manufacturer Narrative
H3: product analysis#: (b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box and within a sealed tyvek biohazard pouch.The axium implant coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium pushwire was found to be kinked at ~6.1cm from proximal end.The axium coil pushwire was found to be broken but retained by release wire at break indicator.The coin was found to be not against the lumen stop.The implant coil was already detached and not returned.No other anomalies were observed.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium implant coil was returned with the implant already detached; however, the root cause could not be determined.It is likely the premature detachment was due to the pushwire break at break indicator causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon opening the package and attempting to remove the product or after removing it from the package and preparing it per ifu.The customer reported preparation was completed to the coil prior to detaching the implant coil prematurely.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 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: 20403159
• Report Number: 9617601-2024-00228
• Device Sequence Number: 20438732
• Product Code: KRD
• UDI-Device Identifier: 00847536037892
• UDI-Public: 00847536037892
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/02/2025

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: QC-8-20-3D
• Device Catalogue Number: QC-8-20-3D
• Device Lot Number: 228484480
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 12/30/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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 Sex: Unknown