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

Model Number	APB-4-12-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #705579644:equipment used: vis m-81805, 203cm ruler m-83360 document used: n/a as found condition (condition of returned device): the axium prime implant coils were both returned for analysis within a shipping box; both axium prime coils returned within individual sealed plastic biohazard pouches and one axium prime coil was returned within a dispenser coil.The reported catheter was returned within package.Damage location details: the axium prime implant coil was returned within the introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end.The introducer sheath was found to be in good condition with no damaged found.The pushwire was found to be bent at ~57.7cm from the proximal end; however, the pushwire was also found to be bent within the introducer sheath at ~78.1cm from the distal end.The axium prime coil was found to be missing (not returned).No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coil could not be used for resistance testing with an in-house micro catheter due to returned condition (damaged).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the cause could not be determined.Advancing the axium prime coil against resistance would result in damage to the pushwire causing the breaks.Other possible contributing causes for resistance include the use of an incompatible device for delivery, tortuous anatomy, or failure to hydrate the axium prime coil prior to use.The customer reported that the patient vessel tortuosity was moderate.The sl-10 micro catheter used in the event was not returned; therefore, any contributing factors (other than inner diameter specification) could not be assessed.Via an online source the sl-10 micro catheter has an inner diameter of 0.0165¿.Via ifu (instructions for use) the axium prime coil should be delivered by a microcatheter with a minimum id of 0.0165¿-0.017¿ with two marker bands; therefore, the sl-10 microcatheter was found to be compatible with the axium prime coil.There was no non-conformance to specifications identified that led to the resistance issue.Durana27 (2023-06-08) 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.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 a report that axium coil deployment was unavailable due to strong resistance in microcatheter.It was reported there was coil resistance/stuck in the middle of the catheter that occurred.The catheter and coil were not damaged.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices include an sl-10 microcatheter.Additional information received thatthe patient was undergoing right internal carotid artery aneurysm coil embolization treatment.Vessel tortuosity was moderate.No patient symptoms or further complications were reported as a result of this event.There are¿no procedural / post-procedural imaging (ct,¿angio, etc.) available.The procedure was completed by using another product.The resistance was located in the middle part of the catheter.The coil came out of the introducer sheath smoothly.

• 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: 17098109
• Report Number: 2029214-2023-00907
• Device Sequence Number: 19309790
• Product Code: KRD
• UDI-Device Identifier: 00847536032019
• UDI-Public: 00847536032019
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 06/09/2023

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: 07/07/2023
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: B050784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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: Unknown