MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number	105-5096-000
Medical Device Problem Codes	Compatibility Problem (2960); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an apollo catheter was occluded during onyx injection.The patient was undergoing surgery for treatment of an arteriovenous malformation.The accessed vessel was to femoral artery with a diameter of 5 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that in the treatment of arteriovenous malformation, the operator used detachable apollo catheter to inject new oscillating onyx.At the end of the catheter, it was difficult to inject and the catheter was blocked, so a new catheter was replaced and the operation went smoothly.It was reported there was catheter resistance in the distal section of the catheter.It was also reported there was catheter occlusion during the onyx injection.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Additional information was received that the anatomical location of the avm was the intracranial occipital lobe.The dead space of the delivery catheter was filled with dmso.There was no friction or difficulty during flushing or injection.There was no kink or damage on the catheter.There was no onyx reflux, it was stuck in the catheter.The physician had continuous injection.The injection waiting time or pause time between the injections was unknown.The injection rate was followed as indicated in the instructions for use.
Additional Manufacturer Narrative
H3: the apollo micro catheter was returned for analysis.Onyx was found within the apollo catheter hub.No bends or kinks were found with the apollo catheter body.The apollo catheter distal tip was found detached from the catheter.The detached tip was not returned.Onyx was found within the apollo catheter distal tip lumen.Based on the device analysis and reported information, the customer¿s ¿catheter occlusion¿ report was confirmed.It is likely that the onyx became exposed to water, saline or blood causing the onyx to solidify.This can occur in the hub, catheter lumen, or the needle used to draw the onyx from the vial.However, the cause 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.

• Brand Name: APOLLO
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• 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: 16988827
• Report Number: 2029214-2023-00834
• Device Sequence Number: 6829211
• Product Code: MFE
• UDI-Device Identifier: 00847536006041
• UDI-Public: 00847536006041
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030004
• 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): 05/23/2023

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: 06/16/2025
• Device Model Number: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: B410064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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