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

Model Number	APB-2-4-3D-ES
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	01/08/2021
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 reporting that the fourth coil used in the procedure, an axium prime coil, detached spontaneously within the microcatheter.The coil and microcatheter were removed from the patient's body together.It was noted that the device was prepared according to the instructions for use.There was no harm or injury to the patient.Other event information was not known at time of the report.
Additional Manufacturer Narrative
Product analysis findings: the axium prime coil (model: apb-2-4-3d-es lot: b059591) was returned for analysis.The actuator interface was found securely attached within the coupler tube and the break indicator was found intact.No detachment attempts using an instant detacher and by manual methods were found at these locations.No damages or irregularities were found with the pusher.The coin was still against the lumen stop.The shield coil was found intact.The shield coil was removed.The release wire was extending out of the retainer ring 0.004¿, which is within specification.The retainer ring was found damaged and the inner diameter could not be reliably measured, however, the largest diameter of the damaged retainer ring is no longer within specification.Dried blood was found within the retainer ring and on the release wire.The axium prime implant coil was found stretched and damaged with the polypropylene filament intact.The detach element stick, loop and ball were found undamaged.The outer diameter of the detach element ball was measured to be 0.0038¿ which is within specification.No other damages or anomalies were found.Based on the device analysis and reported information, the customer¿s report of ¿premature detachment¿ was confirmed as the implant coil was already detached.The likely cause of the detachment is due to the damage found to the retainer ring, causing the detach element to slip out and subsequently detaching the implant coil.Other possible contributors for premature detachment are tortuous anatomy, coil not retracted in a one-to-one motion during repositioning, pushwire rotation, user advances against resistance or damaged pusher.Possible causes for damage to the retainer ring are manipulation of the device against resistance, tortuous patient anatomy, lack of hydration before procedure, user does not maintain continuous flush, coil not retracted in a one to one motion with the implant coil during repositioning, or pushwire rotation.There is no indication that the event is related to a potential manufacturing issue.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, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11167128
• Report Number: 2029214-2021-00049
• Device Sequence Number: 11638279
• Product Code: KRD
• UDI-Device Identifier: 00847536021198
• UDI-Public: 00847536021198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 07/25/2023
• Device Model Number: APB-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: B059591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1