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

Model Number ART19SMT

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the solo smart heart valve, model #icv1246 , s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1246) solo smart heart valve at the time of manufacture and release.The event description refers to a annulus enlargement, so the regurgitation detected may have been a result of an intraoperative mis-sizing.The manufacturer has requested additional information on the event and patient's impact and will provide an update should further information be received.

Event Description

On (b)(6) 2021, a patient underwent an aortic valve replacement procedure.The patient presented with high calcification of valsalva.It was considered to implant a perceval s valve, but since the s size sizer did not pass, a solo valve size 19 mm was implanted.After de-clamping the aorta, regurgitation around the valve was observed (severe).The cross-clamp was re-applied and a repair was attempted.After de-clamp, no improvement was observed.The total cross clamp time was 70 min.The solo valve was ultimately removed and the annulus was enlarged.An inspiris 19 mm was ultimately placed.

• Brand Name: SOLO SMART STENTLESS HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, british columbia V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11521676
• MDR Text Key: 250346525
• Report Number: 1718850-2021-01039
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000450
• UDI-Public: (01)00896208000450(240)ICV1246(17)230707
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021,03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: ART19SMT
• Device Catalogue Number: ICV1246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2021
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 60