MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Endocarditis (1834); Fever (1858); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model # icv1208, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1208 perceval heart valve at the time of manufacture and release.A follow up report will be provided upon receipt of further information.
Event or Problem Description
Manufacturer was informed that perceval valve pvs21 was implanted on (b)(6) 2023 with cabg as concomitant procedure.Reportedly, about three months after surgery, fever and enterococcus infection were noted.Vegetation was also noted on the leaflets of the valve.As reported, in the week of 19 feb 2024, regurgitation was noted.As such, the valve was explanted on (b)(6) 2024.Patient also underwent mvr since infection was also noted with mitral valve.Further information indicated that the patient has previous history of endocarditis in jan 2024.Reportedly, verrucae were present throughout the valve due to enterococcal infection, and the valve had lost its function.Reportedly, patient was treated with antibiotics prior to the explant.There was no impact on the patient and outcome was good.
Additional Manufacturer Narrative
The manufacturing and material records for the perceval heart valve, model # icv1208-jp, serial # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1208 perceval heart valve at the time of manufacture and release.Based on the available information, the root cause of the event could not be established at this time.Reportedly, there is no adverse impact, and outcome was good after the reintervention.Since the explanted device was not returned to the manufacturer, no further investigation on the device could be performed.Moreover, form the document review, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 19442859
• Report Number: 3004478276-2024-00137
• Device Sequence Number: 7107131
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)260907
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/30/2024

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: 09/07/2026
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male