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

Model Number	APB-2.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5 as found condition: the axium prime coil was returned for analysis within a shipping box; within an opened axium prime outer carton and within an opened axium prime inner pouch.The dispenser coil and introducer sheath were also returned.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found fully retracted out of the coupler tube.The break indicator was found broken with the two segments retained by the release wire.The axium prime pusher was found bent/kinked throughout the entire length.The shield coil was found broken.The axium prime implant coil was already detached form the pusher.The implant coil was found damaged and stretched with the polypropylene filament unbroken.Testing/analysis: the axium prime coil could not be used for resistance testing due to the damaged condition and as it was already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damage to the micro catheter, incompatible micro catheter, or tortuous anatomy.Customer reported patient vessel tortuosity as moderate, and devices were prepared per ifu.The returned axium prime implant coil was found damaged/stretched, and the pusher was found kinked/bent.Customer reported no issues and no resistance within the introducer sheath during preparation; therefore, it is possible the damages occurred during the attempt to push the coil into the micro catheter against the reported resistance or during return shipping as the device was returned outside of its protective dispenser coil and introducer sheath.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be assessed.As the model and lot numbers were not reported, compatibility could not be assessed.The actuator interface was found retracted out of the coupler tube and the break indicator was found broken, typically indicative of detachment attempts and the implant coil was found detached as expected by the detachment subassemblies.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 during the coiling procedure while developing the coil, the doctor finds the resistance while pushing the coil and the coil was not moving.The doctor tried one more time and again there was resistance felt while pushing the coil and the doctor had to withdraw the coil.Resistance occurred in the middle section of the catheter.The catheter and coil were not damaged.The reported device and any accessory devices were prepared as indicated in the ifu.It was unknown if any patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured anterior communicating artery (acom) aneurysm with a max diameter of 4.73mm and a 1.45mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Additional information was received.The patient is "doing good" with no symptoms.The coil did come 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: 17844736
• Report Number: 2029214-2023-01899
• Device Sequence Number: 12607822
• Product Code: KRD
• UDI-Device Identifier: 00847536021211
• UDI-Public: 00847536021211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151447
• 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): 09/29/2023

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: 08/14/2023
• Device Model Number: APB-2.5-6-3D-ES
• Device Catalogue Number: APB-2.5-6-3D-ES
• Device Lot Number: B069953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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: Female