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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE
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LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE Back to Search Results
Model Number CNA23
Device Problems Gradient Increase (1270); Material Too Rigid or Stiff (1544); Material Split, Cut or Torn (4008)
Patient Problem Dyspnea (1816)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative
The valve was received for analysis on november 20, 2018.The returned valve appeared slightly deformed with signs of calcification and organic deposition.The leaflets were stiffened.Investigation is ongoing.
 
Event Description
A crown cna23 was implanted on (b)(6) 2015.On (b)(6) 2018, the patient presented with dyspnea.Tte revealed high gradient, and re-do aortic valve replacement was performed.It was reported that the valve had an immobile cusp, with large calcification at the stent posts.A carpentier 21 mm valve was implanted and the patient was recovering well when the event was reported.
 
Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna23, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.Visual and x-ray analysis of the returned device revealed intrinsic and vegetating calcifications in all three leaflets, and a tear on one leaflet.The stent and sewing ring were covered by fibrous pannus that protruded into the lumen, narrowing the annulus.Histological analysis showed that the pericardium was thickened due to intrinsic calcifications.The collagen bundles were disrupted and hmogenated.Fibrous pannus was visible on both surfaces of one leaflet.Red blood cells and inflammatory cells were visible inside the thrombus deposition that was present on the mesothelial surface of one leaflet.Bacteria were not detected with gram staining.Based on the investigations performed, leaflet calcification caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from a leaflet tear and inadequate leaflet coaptation due to calcification.There was no evidence of endocarditis in the returned valve.It is possible that the patient's clinical history and risk factors (hypertension, hyperlipidemia, diabetes) contributed to the reported structural valve deterioration; however, this cannot be confirmed from the investigations performed.
 
Event Description
A crown cna23 was implanted on (b)(6) 2015.On (b)(6) 2018, the patient presented with dyspnea.Tte revealed high gradient, and re-do aortic valve replacement was performed.It was reported that the valve had an immobile cusp, with large calcification at the stent posts.A carpentier 21 mm valve was implanted and the patient was recovering well when the event was reported.The patient's medications are suggestive of hyperlipidemia, hypertension, and diabetes.
 
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Brand Name
CROWN PRT PERICARDIAL HEART VALVE
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP
5005 north fraser way
burnaby, bc
MDR Report Key8127265
MDR Text Key129180398
Report Number3004478276-2018-00357
Device Sequence Number1
Product Code LWR
UDI-Device Identifier00896208000528
UDI-Public(01)00896208000528(240)CNA23(17)191231
Combination Product (y/n)N
PMA/PMN Number
P060038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Model NumberCNA23
Device Catalogue NumberCNA23
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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