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

Model Number PVS

Device Problem Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Manufacturer was informed of the following event through a published paper: "endothelial microparticles: markers of inflammatory response after sutureless valve implantation" by jlr oliveira, et al.As reported in the paper, the aim of this study was to compare the plasma concentration of emp between patients undergoing aortic valve replacement with conventional bioprosthesis implantation and perceval s and to evaluate its impact on the inflammatory response in the short-term follow-up.Based on the information provided in the table of outcomes in the immediate postoperative period, 2 cases of mild paravalvular leak occurred after implantation of peceval valves.No further information is available at this time.

Manufacturer Narrative

H3 other text: unknown disposition.

• Brand Name: PERCEVAL VALVE SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18369773
• MDR Text Key: 331049171
• Report Number: 3004478276-2023-00216
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Model Number: PVS
• Device Catalogue Number: TBD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other