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

Model Number	APB-6-20-3D-SS
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the axium prime implant coil was returned without the introducer sheath.No bends or kinks were found with the axium pushwire.The implant coil was found to be broken and not returned.No other anomalies were observed.The axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the implant coil was found to be broken and not returned.There was no reported issue pushing the axium prime coil out from within the introducer sheath.Therefore, it is possible the axium coil became damaged upon removal from within the introducer sheath or during reported resistance; however, the root cause could not be determined.The model and lot numbers were not provided for the microcatheter; therefore, any contributing factors could not be assessed.Based on the device analysis and reported information, the customer¿s report of ¿resistance/failure to resheath¿ was unable to be confirmed as the implant coil was found to be broken and not returned.The root 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.
Event or Problem Description
Medtronic received a report that the axium prime coil became stretched.The patient was undergoing treatment for a ruptured, saccular vertebral aneurysm.The patient's blood flow and vessel tortuosity were normal.It was reported that the fourth 4th coil the doctor tried to insert was not proper, so they wanted to reposition.They retrieved the coil to insert again, but that coil didn't go back while they pulled the pushwire.At that time the doctor thought the coil had auto detached, so they decide to pull it out of the patient.Finally the coil was able to go out from the patient, at which time it was seen to be stretched very long.There had been no friction or difficulty during testing or delivery.A continuous flush had been administered.The coil had been repositioned 1-2 times.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a non-medtronic guide catheter and microcatheter.Additional information received that the cause of the event was not determined.The doctor was concerned how much the power limit to push or pull coil to avoid this issue.

• 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: 21108259
• Report Number: 9617601-2025-00044
• Device Sequence Number: 8067916
• Product Code: KRD
• UDI-Device Identifier: 00847536038301
• UDI-Public: 00847536038301
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K081465
• 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
• Report Date (Section B): 01/08/2025

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 Expiration Date: 01/19/2025
• Device Model Number: APB-6-20-3D-SS
• Device Catalogue Number: APB-6-20-3D-SS
• Device Lot Number: 223652565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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