MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. APOLLOTM; AGENT, INJECTABLE, EMBOLIC

Model Number	105-5095-000
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent a cerebral angiogram and ethylene-vinyl alcohol copolymer (evoh) embolization.While injecting the embolic agent during the procedure, the agent was observed to be coming out of the catheter at a point proximal to the tip, which led to a stroke.Patient is currently reported to be stable but guarded.Post procedure, the catheter was examined under a microscope and a small hole was found about 6cm from the tip.

• Brand Name: APOLLOTM
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12688356
• Report Number: 12688356
• Device Sequence Number: 17107621
• Product Code: MFE
• UDI-Device Identifier: 00847536006010
• UDI-Public: (01)00847536006010(17)240327(10)B189389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/14/2021
• Report Date (Section F): 10/14/2021

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 Lot Number: B189389
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2021
• 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: Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 10/14/2021