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

Model Number	ART23SMT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
On (b)(6) 2018, a solo smart size 23 was implanted and explanted.No other information was provided.
Additional Manufacturer Narrative
Based on the information provided, there was no problem with the device.The event is attributable to mis-sizing and user error, and no further investigation is warranted.
Event or Problem Description
A solo smart size 23 was implanted and explanted intra-operatively on (b)(6) 2018.It was reported that there was no problem with the valve, and that the event was attributable to mis-sizing.No other information was provided.

• 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 7764881
• Report Number: 3004478276-2018-00274
• Device Sequence Number: 13892427
• Product Code: LWR
• UDI-Device Identifier: 00896208000474
• UDI-Public: (01)00896208000474(240)ICV1248(17)200402
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 04/02/2020
• Device Model Number: ART23SMT
• Device Catalogue Number: ICV1248
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Required Intervention
• Patient Age: 72 YR