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	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the solo smart heart valve, model #icv1247, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1247) solo smart heart valve at the time of manufacture and release.Based on the available information, it is not possible to establish the root cause of the reported event.However, per the document review performed, no manufacturing deficits were identified.The manufacturer has followed up to retrieve additional information on this event, but no further details have been provided to date.Should additional information be received, the manufacturer will update the reporting activity within the required timelines.Unknown disposition.
Event or Problem Description
The manufacturer received information on this event through the device tracking department.Based on the information reported in the patient implant form, a solo smart that was implanted on (b)(6) 2016, was explanted on (b)(6) 2020.No further information is presently available.

• 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: 10532726
• Report Number: 3004478276-2020-00187
• Device Sequence Number: 19591432
• Product Code: LWR
• UDI-Device Identifier: 00896208000467
• UDI-Public: (01)00896208000467(240)ICV1247(17)180122
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P130011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: 01/22/2018
• Device Model Number: ART21SMT
• Device Catalogue Number: ICV1247
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/14/2020
• 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