MAUDE Adverse Event Report: CORCYM CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	CNA21
Medical Device Problem Codes	Calcified (1077); Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that in march 2020, a crown valve (unknown size) was implanted in the patient.Reportedly, the valve was explanted on (b)(6) 2023 since as and ar were noted at the follow-up examination (i.E., ava: 0.72, vmax: over 5m/sec, pg:71mmhg), and the leaflets of the valve was not working correctly.Inspiris 21mm was implanted in the patient as a replacement.
Additional Manufacturer Narrative
A follow up report will be provided upon completion of investigation and/or receipt of any additional information.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by quality engineering at corcym 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.As reported in the scientific literature, structural valve deterioration 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).Based on the information available, patient is taking bisoprolol fumarate and sevelamer hydrochloride which are medications for hypertension and hyperphosphatemia (chronic kidney disease) respectively.As such, it is possible that the patient¿s clinical history and risk factors (i.E., hypertension and chronic kidney disease) may have contributed to the structural valve deterioration observed in this crown prt valve.
Additional Manufacturer Narrative
Valve has been returned to the manufacturer.The stent and the sewing ring were covered by fibrous pannus that on the inflow side protruded 2-4 mm into the lumen, narrowing the annulus, and contributes to stenosis.The pericardium of all three leaflets was thicker than normal due to calcifications.Pericardial delaminations were detected in all leaflets.Small thrombus depositions were visible on all inflow surfaces and on some outflow surfaces.Reddish areas due to coagulated blood entrapment were present on all surfaces.Manufacturer is retrieving and reviewing the product manufacturing documents.A follow up report will be provided upon completion of this review.
Event or Problem Description
The manufacturer was informed that in (b)(6) 2020, a crown valve size 21 was implanted in the patient.Reportedly, the valve was explanted on (b)(6) 2023 since as and ar (central leak) were noted at the follow-up examination (i.E., ava: 0.7^2, vmax: over 5m/sec, pg:71mmhg), and the leaflets of the valve was not working correctly.Inspiris 21mm was implanted in the patient as a replacement.Based on the further information received, patient is still in the hospital.Re-operation for hemodialysis shunt was performed.Based on the medical judgment received, calcification above the entrance of the sinus of valsalva was present in the original crown implant procedure but since it was not in contact with crown, it was not treated.But during the re-operation it was noted that the calcification is in contact with crown.As such, it has been removed.Patient's medications were reported as follow: vonoprazan fumarate, bisoprolol fumarate, evocalcet and sevelamer hydrochloride.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; buranby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby
• MDR Report Key: 18330585
• Report Number: 3004478276-2023-00213
• Device Sequence Number: 12461841
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)210930
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/13/2024

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: 09/30/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 01/12/2024; 02/16/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/11/2024; 02/09/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 41 KG