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

Model Number	CNA21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, 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 crown prt aortic pericardial heart valve at the time of manufacture and release.Further investigation ongoing.
Event or Problem Description
On (b)(6) 2016, a female patient with a history of diabetes, hypertension, and hypercholesterolemia received a crown cna21 in aortic position.The device was explanted on (b)(6) 2019 due to valve stenosis, with the presence of calcification.The explanted crown was replaced by a carbomedics 19mm.The patient is stable and in a regular follow-up course.In the medical records of the patient, there is no information on therapies with the integration of calcium.
Additional Manufacturer Narrative
The device was returned to the manufacturer and it was received on (b)(6) 2019.The gross examination performed confirmed that the valve was received in a deteriored status.In particular, the sewing cuff was damaged and there was pannus growth both on the inflow side and on the valve cusps.Calcification was detected on the leaflets, particularly marked at the junction of the cusps.The pericardium was thickened and stiffened.Further investigation is ongoing.
Additional Manufacturer Narrative
The explanted crown cna21 was returned to the manufacturer and it was received on (b)(6) 2019.The returned valve underwent gross and visual inspection, x-ray and histological analysis.The results showed that the sewing cuff was damaged and there was pannus growth both on the inflow side and on the valve cusps.The pericardium appeared thickened and stiffened.It was observed the presence of intrinsic and vegetating calcifications in all the leaflets, particularly marked at the junction of the cusps.There was pannus overgrowth on the inflow sewing ring of the valve.Calcified thrombus depositions were visible.There was no evidence of endocarditis in the returned valve.Based on the investigation performed, it can be concluded that the leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.The pannus overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from the inadequate leaflets coaptation caused by 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).It is possible that the patient¿s clinical conditions and risk factors (hypertension, coronary artery disease, diabetes, and hypercholesterolemia) may have contributed to the structural valve deterioration observed in this crown valve.

• 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
• MDR Report Key: 8557298
• Report Number: 3004478276-2019-00153
• Device Sequence Number: 16702511
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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: 08/31/2020
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 05/30/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/27/2019; 06/14/2019
• 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: 71 YR