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

Model Number PVS23

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Endocarditis (1834)

Event Type  Injury  

Event Description

This case refers to pt # 5 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 previously had two surgical interventions and was suffering from prosthetic valvular endocarditis (pve).A perceval pvs 23mm was implanted.After 24 months of implantation an echo showed the patient had signs of abscess and mycotic aneurysm.The patient required surgical intervention and a cabrol homograft was implanted.

• 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: 12410714
• MDR Text Key: 269436400
• Report Number: 1718850-2021-01157
• 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?: No
• 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): Required Intervention
• Patient Age: 56 YR