MAUDE Adverse Event Report: LIVANOVA CANADA CORP. SOLO SMART SUPRA-ANNULAR HEART VALVE; TISSUE HEART VALVE

Model Number	ART27SMT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information was reported to livanova by the patient.The solo smart valve was implanted on (b)(6) 2015 at (b)(6) hospital.
Event or Problem Description
The manufacturer was notified on 01-nov-2016 by the patient of the following: a solo smart valve was implanted on (b)(6) 2015.One of the leaflets was not closing.The patient is scheduled for valve-in-valve reoperation.
Additional Manufacturer Narrative
The complete manufacturing and material records for the solo smart heart valve, model icv1265, s/n (b)(4), were retrieved and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model icv1265) solo smart heart valve at the time of manufacture and release.No further information has been received by the manufacturer to date of the proposed tavi procedure, based on the limited information provided, it is not clear what the complete reason for proposed tavi was therefore no conclusion can be drawn.No further investigation is possible at this time.

• Brand Name: SOLO SMART SUPRA-ANNULAR 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: 6133861
• Report Number: 3004478276-2016-00157
• Device Sequence Number: 1310885
• Product Code: LWR
• UDI-Device Identifier: 00896208000498
• UDI-Public: (01)00896208000498(240)ICV1265(17)180226
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: 02/26/2018
• Device Model Number: ART27SMT
• Device Catalogue Number: ICV1265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 11/22/2017
• 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: 79 YR