MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER

Model Number	SFR2-4-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The solitaire device has not been returned for evaluation; product analysis cannot be performed.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the passed away approximately 26 days post successful mechanical thrombectomy procedure.The patient was undergoing mechanical thrombectomy for treatment of an acute ischemic stroke.Prior to the event, the subject had a pre-procedure nihss of 25.Subject had a pre-procedural mtici score of 0.Final pass with solitaire resulted in tici of 2b.24 hours post procedure, the patient had nihss of 19 and was discharged home 6 days post procedure with mrs of 4 and nihss of 6.The reason for death was unknown.

• Brand Name: SOLITAIRE FR2
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8493779
• Report Number: 2029214-2019-00319
• Device Sequence Number: 16647950
• Product Code: NRY
• UDI-Device Identifier: 00847536020719
• UDI-Public: 00847536020719
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 04/08/2019

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: 05/06/2020
• Device Model Number: SFR2-4-20
• Device Lot Number: A644765
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• 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: Death