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 Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the axium prime pushwire was returned for analysis.The axium prime pushwire was returned within the introducer sheath.The axium prime pushwire was found to be inverted within the introducer sheath with the wavelock at the distal end.No bends or kinks were found with the axium prime pushwire.The axium prime implant coil was found to be missing/ broken and detached from axium prime pushwire.The implant coil was not returned therefore; any contributing factors could not be assessed.No damages or irregularities were found with the introducer sheath.The axium prime pushwire was not able to be pushed out from within the introducer sheath due to resistance.The axium prime pushwire could not be used for testing with an in-house microcatheter due to its damaged condition and missing/broken implant coil.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ and ¿coil kink/damage¿ could not be confirmed as the implant coil was found to be missing/broken.The root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.The axium prime pushwire was found to be inverted within the introducer sheath with the wavelock at the distal end which it may also contributed to the damage to the axium prime coil.The vessel tortuosity was moderate.Other possible causes for coil/pushwire damage are: lack of hydration before procedure, user does not maintain continuous flush.It was reported all devices were prepared as per the instructions for use (ifu).Since the micro catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.This regulatory report is being submitted as part of a retrospective review.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 a report that the axium coil was stuck in the catheter.It was reported that during coil deployment the coil got bent and was unable to navigate further.The resistance was encountered in the middle of the catheter.The catheter was not damaged.The device was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient¿s blood flow was normal, and the vessel tortuosity was moderate.Additional information received reported that the coil came out of the introducer sheath smoothly but was later noted to be damaged.The catheter was not manufactured by medtronic.

• 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: 17430435
• Report Number: 2029214-2023-01249
• Device Sequence Number: 2904742
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• 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
• Report Date (Section B): 07/31/2023

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: 04/02/2022
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A809237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Male