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

Model Number	APB-6-15-3D-SS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that broke or detached prematurely.It was reported that the coil came off when inserted in the microcatheter.It is unclear if the physician had attempted coil detachment.There was no friction or other difficulty observed during delivery of the coil.The pushwire was not bent or broken.The coil was removed from the patient; no additional intervention was required.There as no harm or injury to the patient 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.
Additional Manufacturer Narrative
The axium prime coil was expected to be returned for analysis.However, only the outer carton, inner pouch, and introducer sheath were returned.Therefore, an analysis summary is not 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.
Event or Problem Description
2024-jun-21 (b)(4) (hcp, for, dis): medtronic received information regarding an axium coil that broke or detached prematurely.It was reported that the coil came off when inserted in the microcatheter.It is unclear if the physician had attempted coil detac hment.There was no friction or other difficulty observed during delivery of the coil.The pushwire was not bent or broken.The coil was removed from the patient; no additional intervention was required.There as no harm or injury to the patient associated with this event.2024-jul-01 email x2 (rep): no new event information.2024-aug-05 e3 (hcp, for, dis, rep): additional information received reported the orginal lesion characteristics were m1, 6mm, amorphous, left middle cerebral artery (mca).Vessel tortuosity was normal.The device was prepared according to the instructions for use (ifu).The device was hydrated with saline and was no bent on the delivery wire.The procedure was completed by changing to new coils.There was no issues that resulted in the damage that was found.There were no attampts to detach the coil prior to non-detachment.It detached prematurely.The pushwire was still in good shape when taken out from the sheath.Ancillary devices: headway 17 microvention.

• 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: 19637722
• Report Number: 9612164-2024-03043
• Device Sequence Number: 15240446
• Product Code: KRD
• UDI-Device Identifier: 00847536038295
• UDI-Public: 00847536038295
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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 Model Number: APB-6-15-3D-SS
• Device Catalogue Number: APB-6-15-3D-SS
• Device Lot Number: 227937274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 12/14/2023
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 55 KG