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

Model Number	105-5095-000
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rupture (2208); Ischemia Stroke (4418)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
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
It was reported that during a procedure involving the use of onyx for embolization of a distal arteriovenous malformation, several posterior vessels were occluded.The patient, who had a history of arteriovenous malformation open surgery 20 years prior, experienced a bleed from the arteriovenous malformation.The procedure was initially thought to involve a rupture of the apollo catheter, but it was later determined that the catheter remained intact.The bleeding likely occurred when part of the onyx plug, which was not densely packed, ripped the artery as it was being pulled.The most proximal part of the onyx plug broke off- it was loosely attached still in the catheter and when pulled in the guide got detached.The patient was treated as having an ischemic stroke, with attempts made to remove the free-floating onyx using sfr and red 43, although the latter was unsuccessful.A right side external ventricular drain was placed, and the patient was taken for computed tomography.The injection rate was slow hand.  the access vessel was the basilar artery with a diameter of 5mm, and the vessel tortuosity was normal.The catheter was flushed as indicated in the instructions for use (ifu), and there was no friction or difficulty during delivery.The outcome was that the onyx occluded "acceptable" vessels, and the patient was left with an injury.Several posterior vessels occluded with onyx.The healthcare provider (hcp) initially thought the apollo had ruptured.Now he does not believe the apollo ruptured.Manufacturing representative (rep) did see the end of the catheter was stretched.Ancillary devices: 6fr shuttle 90 cm sheath, navien 072 guide catheter , syncro 14 guidewire.
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 received reported that the patient was stable, no better or worse.The patient experienced ischemia in a few locations.The vessel occlusion was treated like a stroke.Aspiration and sfr was used.
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 received reported that not all of the onyx was able to be removed from the patient.It was reported that the bleed/rupture was pre-existing.The patient was undergoing treatment to prevent rupture.The patient had recovered at this time.
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.

• 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: 20882909
• Report Number: 2029214-2024-02262
• Device Sequence Number: 8675762
• Product Code: MFE
• UDI-Device Identifier: 00847536006010
• UDI-Public: 00847536006010
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: B703829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 03/05/2025; 03/10/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/10/2025; 03/06/2025; 04/03/2025
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 65 KG