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

Model Number	APB-6-10-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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 regarding an axium coil that detached within the microcatheter after failed detachment attempts during the procedure.The patient was undergoing coil embolization treatment for a ruptured saccular aneurysm of the posterior internal carotid artery (pica).The aneurysm max diameter was 6.1mm and the neck diameter was 4.3mm.Blood flow was normal.Vessel tortuosity was severe.It was reported that all devices were prepared according to the instructions for use (ifu).The microcatheter was in place well inside the aneurysm.The complaint axium coil was the first coil used.The physician flushed the coil sleeve per ifu by putting the coil sleeve half into the y connector and allowing the saline to flushed through the coil sleeve.The coil was then inserted through the microcatheter hub and the rhv was tightened per ifu.The coil was placed inside the aneurysm and slowly pushed forward.When the physician attempted to detach the coil, it could not be detached.3 attempts were made with one instant detacher without success.A second instant detacher was then tried twice without success.1 attempt was made to detach the coil manually with the hypotube but was also unsuccessful.Finally the coil was going to be removed.When pulling the coil back inside the microcatheter, the physician noticed the coil was inside the microcatheter but coil not be pulled further so the whole system was moved together.The microcatheter was then replaced and new coils were used to complete the procedure.There was no injury to the patient.There were no patient symptoms or complications associated with this event.
Event or Problem Description
Additional information received from the physician indicated that prior to coil non-detachment, there were no issues encountered, and no pushwire¿damage observed after removal from the patient.
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: the axium prime pusher proximal end was found bent and broken.The pusher total length was measured to be 179.0cm.When compared to the pusher drawing, 9.0cm of the pusher¿s proximal end was found missing and not returned.The axium prime pusher was found bent at 2.5cm and 14.0cm from the proximal end.The release wire coin was not against the lumen stop and the implant coil was not attached to the pusher.The detached implant coil was not returned.There was an appearance of dried blood on and within the pusher retainer ring.The pusher lumen stop appears to be in good condition.The inner diameters of the retainer ring and lumen stop could not be measured.The release wire could not be located within the pusher for further analysis.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: 11365769
• Report Number: 2029214-2021-00194
• Device Sequence Number: 16341830
• Product Code: KRD
• UDI-Device Identifier: 00847536008250
• UDI-Public: 00847536008250
• 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): 01/04/2022

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: 10/29/2021
• Device Model Number: APB-6-10-3D-SS
• Device Catalogue Number: APB-6-10-3D-SS
• Device Lot Number: A731886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 06/12/2021; 12/19/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 06/16/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 61 KG