MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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
Additional information was received.No instant detacher was used.2 attempts were made to detach the coil using the manual method.Prior to coil non-detachment, no issues were encountered.There was no pushwire damage observed after removal from the patient.The cause of the event was not determined.
Additional Manufacturer Narrative
Continuation of d10: product id: id-1-5 (lot: unknown).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 surgery at the c6 location, involving an unruptured saccular aneurysm, the axium prime coil could not be detached.The aneurysm had a maximum diameter of 3.98 millimeters and a neck diameter of 3.23 millimeters.The patient's blood flow and vessel tortuosity were normal.The coil was replaced during the procedure, and the surgery continued without any complications.The patient did not experience any injury or symptoms.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): an axium prime coil was returned within a shipping box and within a sealed biohazard bag.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface was found to intact and attached to the coupler tube.There did not appear to be evidence of mechanical detachment using an instant detacher at this location.No bends or kinks were found with the axium prime pushwire.This is indicative that a manual detachment was not attempted.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant coil was found stretched and damaged with the polypropylene filament intact.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coil was then used with an in-house instant detacher for detachment testing.No difficulty was experienced inserting the pushwire into the instant detacher, and the load indicator was not visible when the pushwire was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.Conclusion: based on the analysis performed, the axium prime coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached.However, the implant coil was successfully detached mechanically during testing.The implant coil was found damaged.Possible causes for coil damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment as the device was returned without its dispenser coil.The root cause for reported ¿non-detachment¿ could not be determined as all parts of the returned pushwire which could affect the detachment appeared to be in good condition.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.No instant detacher was used.2 attempts were made to detach the coil using the manual method.Prior to coil non-detachment, no issues were encountered.There was no pushwire damage observed after removal from the patient.The cause of the event was not determined.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20708299
• Report Number: 9617601-2024-00312
• Device Sequence Number: 21242309
• 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): 02/05/2025

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 228392606
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 01/16/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/10/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Female