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

Model Number	APB-4-10-3D-SS
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	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an axium coil that detached prematurely.The patient was undergoing a coil embolization procedure to treat an unruptured saccular internal carotid artery (ica) ophthalmic segment aneurysm.The aneurysm max diameter was 14mm and the neck diameter was 4mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed continuously during the procedure.When the physician was attempting to deploy the coil, it detached by itself.There was no friction or other difficulty during delivery.The physician had not repositioned or attempted to detach the coil.A snare was used to remove the coil from the patient's vessel.Another manufacturer's product when then used to complete the procedure.There was no harm or injury to the patient.
Event or Problem Description
Additional information was received indicating there was no kink/damage to the pushwire.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3.Product analysis summary: equipment used: vis (m-81805), 203cm ruler (m-83360).As found condition: the axium prime coil was returned for analysis within a primary shipping box, within a secondary shipping box, within an opened axium prime coil outer carton (a958471), within an opened axium prime coil inner pouch (a958471), and within a dispenser coil.Visual inspection/damage location details: the axium prime coil was returned within its introducer sheath.No damage was found with the introducer sheath.The implant coil appears to be in good condition within the introducer sheath.The axium prime coil was pushed out from within its introducer sheath without issue.The pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.No bends or kinks were found with the pusher.The implant coil was found still attached to the pusher and in good condition.Conclusion: based on the device analysis and reported information, the customer¿s ¿premature detachment¿ report could not be confirmed, and the cause could not be determined.No defect was found with the returned axium prime coil that would have contributed to the event.H6.Coding updated based on analysis results.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13918905
• Report Number: 2029214-2022-00479
• Device Sequence Number: 20396040
• Product Code: KRD
• UDI-Device Identifier: 00847536032002
• UDI-Public: 00847536032002
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 06/03/2022

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: 01/10/2023
• Device Model Number: APB-4-10-3D-SS
• Device Catalogue Number: APB-4-10-3D-SS
• Device Lot Number: A958471
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 05/13/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 04/11/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2020
• 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: 66 YR
• Patient Sex: Male