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

Model Number	PVS25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/07/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer is following up with the healthcare facility to retrieve additional information on the event and the device involved.A follow up report will be submitted upon receipt of any new information or at the conclusion of the investigation.
Event or Problem Description
The manufacturer became aware through device tracking information that a patient implanted on (b)(6) 2022 with a perceval sutureless aortic prosthesis pvs25 passed away on the same day as the procedure.Based on the information retrieved from the operational report, pre-procedure diagnosis was aortic valve endocarditis and retained aicd hardware.The surgery was performed through median sternotomy.After opening the aorta, the posterior leaflet of the native aortic valve wad found totally engulfed with vegetation.This was carefully debrided and all leaflets were excised.99% alcohol was then administered topically to the aortic annulus to kill any other microscopic disease that might had been present.The ventricle was then thoroughly irrigated with antibiotic containing normal saline solution.The valve was sized and the perceval size l prosthesis was implanted.It was noted that there was almost an abscess in the aortic valve annulus which had to be closed.Subsequently, the 2 leads part of aicd hardware were located and removed in their scar sleeve.The corkscrew in the atrium and the corkscrew in the ventricle were thoroughly removed.According to the operational report, there was quite a bit of bleeding which started before the aorta was opened.In addition, diffuse oozing was reported.Weaning from by-pass was performed without difficulty.Both sides of chest were opened as serous fluid, which didn't appear infected, was removed, 2 l from he right side and 3l from the left side.The patient required transfusion of packed cells (8 units packed rbc), ffp (2 units per), platelets (2 units).Cardiopulmonary bypass time was 131 minutes and cross-clamp time was 113 minutes.Coagulopathy was the only reported complication.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h3, h6, h11.The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.
Event or Problem Description
The manufacturer became aware through device tracking information that a patient implanted on 07 march, 2022 with a perceval sutureless aortic prosthesis pvs25 passed away on the same day as the procedure.Based on the information retrieved from the operational report, pre-procedure diagnosis was aortic valve endocarditis and retained aicd hardware.The surgery was performed through median sternotomy.After opening the aorta, the posterior leaflet of the native aortic valve wad found totally engulfed with vegetation.This was carefully debrided and all leaflets were excised.99% alcohol was then administered topically to the aortic annulus to kill any other microscopic disease that might had been present.The ventricle was then thoroughly irrigated with antibiotic containing normal saline solution.The valve was sized and the perceval size l prosthesis was implanted.It was noted that there was almost an abscess in the aortic valve annulus which had to be closed.Subsequently, the 2 leads part of aicd hardware were located and removed in their scar sleeve.The corkscrew in the atrium and the corkscrew in the ventricle were thoroughly removed.According to the operational report, there was quite a bit of bleeding which started before the aorta was opened.In addition, diffuse oozing was reported.Weaning from by-pass was performed without difficulty.Both sides of chest were opened as serous fluid, which didn¿t appear infected, was removed, 2 l from he right side and 3l from the left side.The patient required transfusion of packed cells (8 units packed rbc), ffp (2 units per), platelets (2 units).Cardiopulmonary bypass time was 131 minutes and cross-clamp time was 113 minutes.Coagulopathy was the only reported complication.Based on further information received, the cause of death was attributed to cardiac arrest and stone heart.Reportedly, autopsy was not performed.
Additional Manufacturer Narrative
Since the device was not returned, the manufacturer was unable to conduct a direct investigation on the prosthesis involved in this event.Despite additional good faith efforts to gather more insights on the event and the device were made by the manufacturer, no further information was provided by the site.Consequently, a definitive root cause for the reported event could not be established.It should be noted, however, that the patient was at risk for cardiac arrest as an aicd carrier and had also experienced surgical complications in the context of endocarditis.In any case, the involvement of the device as a cause or contributing factor to the reported event cannot be excluded based on the available information.Should further information be received in the future, the manufacturer will submit an additional follow-up report.

• 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: 20479432
• Report Number: 3004478276-2024-00180
• Device Sequence Number: 18209546
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)240722
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

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: 07/22/2024
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 04/02/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/20/2024; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2021
• 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: Death
• Patient Age: 65 YR
• Patient Sex: Male