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

Model Number	PVS27
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon receipt of any further information or the return of the device.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2022, central leak and paravalvular leak was observed by tee after implanting the perceval valve size xl through full sternotomy.Reportedly, this perceval valve was implanted before coronary artery bypass and heart luxation.Ultimately, it was decided to remove the valve.Another xl valve was ultimately implanted in the patient with a good result.Based on the further information received, no malfunction with the valve was noted, there was no impact on the patient, approximately 20 minutes was added to the procedure as a result of the reported event, and patient was stable through the delay in the procedure.Based on the medical judgement received, it is possible that device dislodgment has been occurred due to the maneuvers and led to the reported regurgitation.
Additional Manufacturer Narrative
Corrected data: h6.Conclusion will remain the same.
Additional Manufacturer Narrative
Based on the medical judgment received, there was no malfunction with the valve, and it is possible that the cause of the reported event was attributed to the valve dislodgement due to the heart maneuvers after the implant of the device.Furthermore, from the document review performed, no manufacturing deficiencies were identified.Should the device or further information be received in the future, the manufacturer will provide a follow up report.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.After decontamination, the visual inspection performed on the returned prosthesis confirmed the absence of pre-existing defects.The hydrodynamic testing was conducted on the pvs 27/xl.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 3.36 cm2, above the iso 5840 minimum requirement 1.70 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 5,4 % and it is below the requirement of iso 5840 (rf% < 15%) for a prosthesis of equivalent tad.No anomalies were observed during the open/close cycle in both normotensive and hypotensive conditions regarding the total and full coaptation of the leaflets.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved device because no regurgitation and no open/close anomalies were observed during the functional test under hydrodynamic testing conditions.From the document review performed; no manufacturing deficiencies were identified.Based on the medical judgment received, there was no malfunction with the valve, and it is possible that the cause of the reported event was attributed to the valve dislodgement due to the heart maneuvers after the implant of the device.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby
• 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: 16187661
• Report Number: 3005687633-2023-00096
• Device Sequence Number: 2661106
• Product Code: LWR
• UDI-Device Identifier: 08022057014726
• UDI-Public: (01)08022057014726(240)ICV1211(17)260606
• 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: 2022
• Device Explanted Year: 2022
• 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): 04/27/2023

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: 06/06/2026
• Device Model Number: PVS27
• Device Catalogue Number: ICV1211
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 03/20/2023; 03/20/2023; 03/28/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/20/2023; 03/20/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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 Sex: Unknown