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

Model Number	APB-3-6-3D-ES
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received information regarding an axium coil that was damaged.The patient was undergoing a coil embolization procedure to treat an unruptured saccular internal carotid artery c5 segment aneurysm.The aneurysm max diameter was 4.5mm and the neck diameter was 2.6mm.Blood flow and vessel tortuosity were normal. it was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.The coil was delivered through the microcatheter and pushed out to form the hoop but it was found that the axium coil device was broken.It was noted that the damage was to the coil and the pushwire was kinked.The microcatheter was withdrawn from the patient's body and the coil was replaced with another of the same model to continue.Other coils were successfully delivered and implanted afterward to complete the procedure successfully.There was no harm or injury to the patient.
Additional Manufacturer Narrative
H3.Product analysis: ¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ as found condition: the axium prime coil was returned for analysis within a shipping box, within a plastic bio-pouch, and within a dispenser coil.¿ visual inspection/damage location details: the axium prime pusher actuator interface (ai) and hypotube break indicator (hbi) were intact.The pusher was found bent at ~8.3cm from the distal end.The release wire coin was found still against the lumen stop.The implant coil was found to have broken off from the pusher from the coil shell weld.In addition, the implant coil polypropylene filament broke off from the detach element.The broken implant coil was not returned.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿coil separation/break¿ and ¿pusher kink/damage¿ reports were confirmed.Possible causes of ¿coil separation/break¿ include tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pusher rotation, or user advances coil against resistance.Possible cause of ¿pusher kink/broke¿ include user advances coil against resistance.However, the cause for the damages could not be determined.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: 15509580
• Report Number: 2029214-2022-01642
• Device Sequence Number: 5070404
• Product Code: KRD
• UDI-Device Identifier: 00847536021235
• UDI-Public: 00847536021235
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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: 10/31/2024
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 223206496
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2021
• 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: 53 YR
• Patient Sex: Female