MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	FC-25-50-3D
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime coil was returned within a shipping box; within another shipping box; within plastic wrap; within an opened axium prime coil outer carton; within an opened axium prime coil inner pouch and within a dispenser coil.Visual inspection: the axium prime coil was returned without the introducer sheath.The implant coil was found to be broken from the distal end of the pusher.And damaged.No other anomalies were observed.No bends or kinks were found with the axium prime pusher.The shield coil was found stretched.The release wire coin was found against the lumen stop.The implant coil was found not attached to the pusher.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 implant coil was found stretched and damaged.No other anomalies were observed.Testing analysis: the axium prime coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in catheter¿ and ¿coil kink/damage¿ reports were confirmed.Advancing the axium prime coil against resistance would result in damage to the implant coil subsequently causing the implant coil to stretch and break off from the pusher.Possible contributing factors include the use of a damaged catheter, incompatible catheter, lack of hydration before the procedure, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.Information regarding the patient¿s vessel tortuosity and the use of a continuous flush was not provided.The echelon-10 microcatheter used for the event was not returned.Therefore, the condition of the echelon-10 could not be assessed.The echelon-10 microcatheter has an id (inner diameter) of 0.017¿.As per the ifu, ¿axium prime detachable coils should only be delivered through a microcatheter with a minimum inside diameter of 0.0165¿ ¿ 0.017¿ with two marker bands.Therefore, the echelon-10 microcatheter was found to be compatible with the axium prime coil.The cause for the reported resistance could not be determined.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 reporting that the framing coil was the first to be used in the procedure.The coil had resistance and became stuck in the echelon microcatheter.The surgeon removed the system.There was no damage noted to the catheter but the coil was observed to be damaged.The patient vessel was re-accessed and the replacement coils were delivered and detached without issue.It was noted the framing coil and all accessory devices were prepared according to the instructions for use (ifu) and the catheter was flushed continuously per ifu.There were no patient symptoms or complications associated with this event.The patient was undergoing a coil embolization procedure to treat unspecified neurovascular abnormalities.Additional information was received.The resistance occurred in the distal section of the catheter.The coil did come out of the introducer sheath smoothly.

• Brand Name: AXIUM FRAMING COIL
• 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: 15136938
• Report Number: 2029214-2022-01274
• Device Sequence Number: 20654537
• Product Code: KRD
• UDI-Device Identifier: 00847536034488
• UDI-Public: 00847536034488
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K162704
• 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
• Report Date (Section B): 07/31/2022

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: 08/22/2023
• Device Model Number: FC-25-50-3D
• Device Catalogue Number: FC-25-50-3D
• Device Lot Number: B074542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2022
• Initial Report FDA Received Date: 07/31/2022
• Date Device Manufactured: 08/22/2020
• 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 Sex: Male