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

Model Number	105-5095-000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition: the apollo catheter was returned for analysis within a shipping box and inside of a sealed plastic biohazard pouch; in addition, a navian guidecatheter was returned for assessment.Visual inspection/damage location details: no flash or molded voids were observed in the hub.The catheter body was found in good condition.The detachable tip was found to be detached and not returned.Testing/analysis: the total and usable length of the apollo catheter were both unable to be accurately measured.The catheter was flushed with water, and no water exited the distal tip.Next a 0.011¿ mandrel was hydrated and was advanced into the catheter hub where it met resistance within the catheter body at ~71.6cm from the hub.Due to its damaged condition, the catheter could not be used for resistance testing with an in-house guide catheter.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was able to be confirmed.The apollo catheter was returned in good condition; however, the detachable tip was not returned.The likely cause of resistance was determined to be material occludes catheter.During testing no water was able to exit the distal it, and resistance was able to be reproduced within the middle segment of the catheter body.No further testing was performed with the catheter body.No guidewire was mentioned in the report.It was noted that the patient's vessel tortuosity was moderate.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that there was catheter resistance in the distal section of the catheter.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The patient was undergoing surgery for treatment of arteriovenous malformation.It was noted the patient's vessel tortuosity was moderate.The access vessel was the femoral artery with a diameter of 2mm.The patient is alive with no injury.
Additional Manufacturer Narrative
H3: product analysis as found condition: the apollo catheter was returned for analysis within a shipping box and inside of a sealed plastic biohazard pouch; in addition, the navian guide catheter was returned for assessment.Visual inspection/damage location details: no flash or molded voids were observed in the hub.The catheter body was found in good condition.The detachable tip was found to be missing and not returned.The distal shaft was found to be in good condition.No other anomalies were observed.Testing/analysis: the total length of the apollo catheter was unable to be accurately measured.An attempted to flush the catheter was made; however, the attempted failed as no water was able to pass through the catheter body.Next a 0.011¿ mandrel was hydrated and was advanced into the catheter hub where it met resistance within the catheter body at ~71.6cm from the hub.Finally, the guidewire was rehydrated and advanced through the distal tip where the mandrel met resistance within the distal segment ( at ~16.1cm from the distal shaft).The catheter body was cut opened and found to be full of solidified onyx/solution, which started from the proximal shaft (~71.6cm), and ending in the distal shaft (~16.1cm).The ldpe overlap was measured to be 1.3mm, which is within specification (1.0-2.5mm).No further testing was performed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was able to be confirmed, as resistance was able to be reproduced within the catheter body (middle and distal segment).A few possible causes of catheter resistance are but not limited to, incompatible devices, patient vessel tortuosity, flush rate too low, material occludes catheter, and/or insufficient catheter flushing or lack of continuous flush; however, the root cause was unable to be determined.It was noted that the patient's vessel tortuosity was moderate, which could be another possible cause for resistance to occur within the catheter.No mention of a continuous flush being administered during the procedure was reported.During testing the catheter failed to be flushed.The catheter body was found to be occluded with solidified onyx/saline solution; in addition, the solidified substance was able to be dissolved under water.No guidewire was mentioned in the report.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23830095
• Report Number: 2029214-2025-02655
• Device Sequence Number: 12010141
• Product Code: MFE
• UDI-Device Identifier: 00763000446741
• UDI-Public: (01)00763000446741(17)260507(10)B565850
• 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,Followup
• Report Date (Section B): 01/21/2026

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: 05/07/2026
• Device Model Number: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: B565850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 56 KG