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

Model Number	APB-4-6-3D-SS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Refer to manufacturer report 2029214-2020-01003 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the first axium coil experienced resistance during delivery in the echelon microcatheter.When the physician pulled back on the coil, the coil was detached inside the catheter.It was noted repositioning was performed 2-3 times, no detachment attempts were made, and a continuous flush had been administered.Since the coil was inside the catheter, both devices were removed together.A second coil axium coil was then delivered, but when the physician tried to pull the coil back out of the vessel, it completely detached: part in the a1 and part in the m1.The coil was flushed in the m3 segment, and a solitaire retriever was used to remove the coil from the patient.It was noted repositioning with this coil was done 2-3 times, rotation of the pushwire was done, and a continuous flush was also administered.Replacement devices were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), the patient's blood flow and vessel tortuosity were normal, and no patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
See related regulatory report 2029214-2020-01003.The actuator interface was found securely attached to the coupler tube.There is no evidence of any detachment attempts using the instant detacher.No damages or irregularities were found with the pushwire.The coin was still against the lumen stop.The shield coil was found intact and the implant coil was still attached to the pusher.The implant coil was found damaged.No other damages or anomalies were found.Based on the device analysis and reported information, the customer report of ¿premature detachment¿ was not confirmed as the implant coil was still attached to the pushwire.There was no evidence of any detachment attempts using an instant detacher or by breaking the break indicator.The implant coil was found damaged.Possible causes for implant coil damage are patient vessel tortuosity, advancing the device against resistance, or damage during return shipping as the device was returned without its protective dispenser coil or introducer sheath.The echelon catheter has an inner diameter of 0.0165¿, which is compatible for use with the axium prime coil per ifu.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: 10640101
• Report Number: 2029214-2020-01004
• Device Sequence Number: 2578019
• Product Code: KRD
• UDI-Device Identifier: 00847536008144
• UDI-Public: 00847536008144
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 04/10/2023
• Device Model Number: APB-4-6-3D-SS
• Device Catalogue Number: APB-4-6-3D-SS
• Device Lot Number: B006890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1