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

Model Number	105-5095-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Hemorrhage, Subdural (1894); Perforation of Vessels (2135)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See manufacturer reports # 2029214-2020-01012, 2029214-2020-01013, and 2029214-2020-01014 for issues with the first apollo catheter and onyx vials.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that during the initial embolization, the doctor complained of the onyx not feeling smooth, the injection was coming in columns, breaking off, and poor visualization.The speed setting on the shaker was 8, and the onyx was shaken for more than 20 minutes.It was noted the vials did not sit for more than five minutes prior to injection since injection was performed immediately after shaking.The onyx was changed out to continue embolization.Later in the procedure, the doctor decided to embolize a different feeder to the arteriovenous malformation (avm), but upon connecting the syringe, there was high resistance due to catheter occlusion, and the doctor was unable to visualize the onyx again.Injection was stopped, and the catheter was changed out.The vessel was re-catheterized, and a different batch of onyx was prepared.Embolization went as normal, but when pulling the catheter out after a few minutes of injection, the patient encountered a bleed in the vessel.The vessel was accessed again, and the bleed was successfully arrested.It was unclear if there was any issue with the catheter or onyx.However, it was realized the onyx vials lot number was a976615 while the packaging stated a992791.Post-procedure expert computerized tomography (ct) imaging showed the patient had a small subdural and subarachnoid bleeding.It was reported that all devices were prepared per the instructions for use (ifu).The patient was undergoing surgery for treatment of an arteriovenous malformation (avm) in the eloquent region.It was noted the patient's vessel tortuosity was moderate.Additional information received reported that only 4 of the 10 vials used had the packaging issue.There had been no damage or evidence of tampering to device packaging.The second catheter used was an apollo.A cause for the bleed in the vessel was not determined, though the doctor theorized it may have been a vasospasm.The patient was recovering from the procedure.No additional adverse events or any medical/surgical interventions have been performed to treat the hemorrhaging.
Event or Problem Description
Additional information received reported that the patient was currently recovering.There had been no long pauses of over 2 minutes during the injection.There was no resistance noted during the dmso injection.
Additional Manufacturer Narrative
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
• MDR Report Key: 10727945
• Report Number: 2029214-2020-01044
• Device Sequence Number: 14204807
• Product Code: MFE
• UDI-Device Identifier: 00847536006010
• UDI-Public: 00847536006010
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: 105-5095-000
• Device Catalogue Number: 105-5095-000
• Device Lot Number: A908397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR