MAUDE Adverse Event Report: LIVANOVA CANDA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number	CNA23
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); No Information (3190)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A gross examination was performed on the returned prosthesis on 22 oct 2018.The returned prosthesis valve was received with traces of organic depositions.In general, the valve appears completely deteriorated.Further investigation is in process.
Event or Problem Description
On (b)(6) 2016 the patient was implanted with a crown prt in aortic position.On (b)(6) 2018, the valve was explanted due to valve dysfunction.Calcification was observed in all tissues (leaflets, aorta, pericardium).
Additional Manufacturer Narrative
The visual examination, x-ray analysis, and histological exams confirmed that the valve revealed a deformed prosthesis due to large intrinsic calcifications in all the leaflets.Large rectangular areas from all the leaflets were missing.The histological analysis also highlighted that collagen bundles were disrupted in two of the leaflets, homogenated and-or defibrated.Cholesterol clefts were also detected.There was no sign of endocarditis on the returned prosthesis.Finally, 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 livanova canada corp.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.Based on the investigation performed, the calcification observed on this crown prt caused stiffening of the leaflets and led to the progressive valve stenosis.Aortic insufficiency likely resulted from the leaflets¿ tears and the inadequate leaflets coaptation caused by their calcification.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).Histological analysis showed the presence of lipid infiltration (cholesterol clefts) in the pericardial tissue.This lipid infiltration may contribute to localized leaflet stiffness, as also supported by the scientific literature.If this event is associated with a degeneration of collagen fibers, as detected in the samples from this valve, it may also lead to leaflet tearing.In conclusion, it is possible that the patient¿s clinical history and risk factors (diabetes mellitus type 2, abdominal obesity, hyperlipidemia) may have contributed to the structural valve deterioration observed in this crown valve.However, the root cause could not be established.Structural valve deterioration is listed among the potential adverse events associated with cardiac valve replacement in the crown prt instructions for use.As such, the event is a known risk associated with the procedure.
Event or Problem Description
On (b)(6) 2016 the patient received a crown prt to replace the native stenotic aortic valve.On (b)(6) 2018, the valve was explanted due to valve dysfunction.The pre-operative echo showed a transvalvular mean gradient of 50mmhg and an effective orifice area of 0.7cm2.The aortic prosthesis appeared extremely calcified, with a grade 2 aortic insufficiency.The aorta appears rigid, with hard fibrosis and important calcification, with a behavior similar to the one of the porcelain aorta.The calcification was observed in all tissues.The explanted crown prt was replaced with a carbomedics size 21.The outcome of the patient after the surgery is good.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 8044620
• Report Number: 3004478276-2018-00328
• Device Sequence Number: 1302232
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)200630
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2018

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: 06/30/2020
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR