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

Model Number	SFR2-4-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that there was a presence of emboli in a new territory following procedure.The patient was admitted to the hospital for an acute ischemic stroke with a pre-procedure nihss of 15 and a pre-procedural mtici score of 0.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that there was a presence of emboli in a new territory following procedure.The patient was undergoing a balloon angioplasty procedure.There was no tandem occlusion.The patient was admitted to the hospital for an acute ischemic stroke with a pre-procedure nihss of 15 and a pre-procedural mtici score of 0.The mtici following the final pass with the initial neurothrombectomy was 0, with a post procedure score of 2b.

• Brand Name: SOLITAIRE FR2
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7818953
• Report Number: 2029214-2018-00747
• Device Sequence Number: 1188511
• Product Code: NRY
• UDI-Device Identifier: 00847536018464
• UDI-Public: 00847536018464
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K123378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 06/28/2019
• Device Model Number: SFR2-4-40
• Device Catalogue Number: SFR2-4-40
• Device Lot Number: A483809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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: Other
• Patient Age: 77 YR
• Patient Weight: 50