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

Model Number	105-5096-000
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that during an arteriovenous fistula embolization procedure, the microcatheter (model 105-5096-000, lot number b780751) and guidewire were opened.Upon inspection of the microcatheter (model 105-5096-000, lot number b780751) out of package and during preparation, a fracture was found at the detachment segment.The package was not damaged and showed no evidence of tampering.The broken location was at the distal end.Subsequently, another microcatheter (model 105-5096-000, lot number b780751) was opened and pushed to the intermediate catheter.It was delivered normally, and treatment was initiated.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.It was noted that the patient's vessel tortuosity was moderate.The access vessel was the right femoral artery, with 7mm diameter.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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
Additional information was received stating that the lesion was an arteriovenous fistula.The cause of the damage was not determined.The device packaging was not damaged on delivery.There were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
H3: product analysis as found condition: the apollo catheter was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, an opened apollo inner pouch, and within a dispenser coil.No guidewire was returned.Damage location details: no damages were found with the apollo catheter hub; however, dried blood residue was found on and inside the hub and strain relief.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.No other anomalies were found.Testing/analysis: the ldpe overlap was measured to be 1.5mm, which is within specification (1.0-2.5mm) conclusion: based on the device analysis and the information provided, the customer's report of "catheter separation/break" was confirmed, as the apollo catheter detachable tip was found to be detached, and not returned for assessment.A possible cause for the tip detachment may have occurred while removing the catheter from the packaging, and/ or during preparation; however, the root cause was unable to be determined.Any contribution the detachable tip had towards the separation was unable to be assessed; in addition, the reported ¿fracture at the detachable segment¿ was unable to be confirm.Based on the device analysis and the information provided, the customer's report of "damaged packaging¿ and ¿prod damaged/deformed out of pkg" were both unable to be confirmed.The apollo hub was returned with dried blood on the hub, which indicates that the device may have been used; however, this could not be determined.No root cause could be determined.Regarding the returned packaging, it was found to be in good condition.No outer carton was returned for assessment; therefore, any damaged done prior to opening the outer carton, was unable to be verified.No cause was able t o be determined.The guidewire mentioned in the report was not returned; therefore, any contribution the guidewire had towards the detachment was unable to be verified.It was noted that the patient's vessel tortuosity was moderate.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (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: 23479878
• Report Number: 2029214-2025-02337
• Device Sequence Number: 10202984
• Product Code: MFE
• UDI-Device Identifier: 00763000446758
• UDI-Public: (01)00763000446758(17)270815(10)B780751
• 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,Followup
• Report Date (Section B): 01/12/2026

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 Model Number: 105-5096-000
• Device Catalogue Number: 105-5096-000
• Device Lot Number: B780751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 12/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/04/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 68 KG