MAUDE Adverse Event Report: LIVANOVA CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE

Model Number	ART21SMT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is part of capa (b)(4) events identified as possible complaints related to valve re-intervention.No further event details were provided.This case is being reported to fda in a conservative way, and no possible investigation will be performed at this time.Valve not available for return.
Event or Problem Description
Based on capa (b)(4) investigation: this case refers to a solo smart valve size 21, implanted on (b)(6) 2015 in aortic position and replaced with mitroflow valve dla21 on (b)(6) 2016.No further event details were provided.This case is being reported to fda in a conservative manner.

• Brand Name: SOLO SMART STENTLESS HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 8317285
• Report Number: 3004478276-2019-00120
• Device Sequence Number: 16556527
• Product Code: LWR
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(17)180124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 01/24/2018
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/07/2019
• 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: Required Intervention
• Patient Age: 60 YR