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

Model Number PVS23

Device Problem Perivalvular Leak (1457)

Patient Problems Aneurysm (1708); Endocarditis (1834)

Event Type  Death  

Event Description

This case refers to pt # 1 of 14 : based on information received from the paper "endocarditis on a perceval s sutureless prosthesis.A new valve with a new form of clinical presentation" by m.V.Groba-marco.The patient was suffering from prosthetic valvular endocarditis (pve).A perceval pvs 23mm was implanted.After 7 months of implantation an echo showed the patient had a periprosthetic leak, vegetations and a mycotic aneurysm.The patient died intra-operatively.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 12410530
• MDR Text Key: 269436089
• Report Number: 1718850-2021-01153
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

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: No Information
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Distributor Facility Aware Date: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR