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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE
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LIVANOVA CANADA CORP. SOLO SMART STENTLESS HEART VALVE; TISSUE HEART VALVE Back to Search Results
Model Number ART19SMT
Device Problems Leak/Splash (1354); Perivalvular Leak (1457)
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 (b)(4).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.
 
Manufacturer Narrative
Since the device was not returned to the manufacturer, no further investigation is possible at this time.Based on the information available, reporting that an annular enlargement was performed after the solo valve explant, it is possible that the solo smart valve size 19mm was oversized thus contributing to the event.Ultimately, based on the medical judgment received, the root cause of the intraoperative perivalvular leak can be traced to non-device related factors.In fact, it is reported that patient's factors (i.E.High calcification) and the surgical technique are believed to have contributed to the event.
 
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 (i.E.Perivalvular leak) was observed (severe).The cross-clamp was re-applied and a repair was attempted (further details were not provided from the site).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.Based on the medical judgment received, it was commented that the high calcification and the surgical technique are believed to have contributed to this event.No information on possible mis-sizing was provided from the site.The patient remained stable during the procedure and had a good outcome.
 
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Brand Name
SOLO SMART STENTLESS HEART VALVE
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP.
5005 north fraser way
burnaby, bc
MDR Report Key11521684
MDR Text Key252137581
Report Number3004478276-2021-00137
Device Sequence Number1
Product Code LWR
UDI-Device Identifier00896208000450
UDI-Public(01)00896208000450(240)ICV1246(17)230707
Combination Product (y/n)N
PMA/PMN Number
P130011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/07/2023
Device Model NumberART19SMT
Device Catalogue NumberICV1246
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight60
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