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

Model Number	ART23SMT
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on (b)(4) 2016 of the following: a solo smart size 23mm was implanted in the patient and in the intra-operative tee, a mild ai was detected.The solo smart valve was explanted.
Additional Manufacturer Narrative
The explanted valve was not returned for analysis.The complete manufacturing and material records for the solo smart heart valve, model icv1248, s/n (b)(4), were pulled 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 icv1248) solo smart heart valve at the time of manufacture and release.

• Brand Name: SOLO SMART AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6094151
• Report Number: 3004478276-2016-00144
• Device Sequence Number: 736761
• Product Code: LWR
• UDI-Device Identifier: 00896208000474
• UDI-Public: (01)00896208000474(240)ICV1248(17)200314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: 03/14/2020
• Device Model Number: ART23SMT
• Device Catalogue Number: ICV1248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 06/07/2017
• 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: 64 YR