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

Model Number PVF-XL

Device Problem Insufficient Information (3190)

Patient Problems Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/10/2023

Event Type  Injury  

Event Description

Manufacturer was informed of the following event through device tracking department.Based on the information on patient implant form, on 10 oct 2023, a perceval plus valve size xl was ''disposed''.Further information from the site confirmed that the device was implanted earlier, and within 2 months post op, a permanent pacemaker was implanted.As pve with severe paravalvular insufficiency, subannular abscess, and disconnection of the av region were developed, the perceval valve was explanted on (b)(6) 2023.Reportedly, while explanting the valve, extensive vegetative material was noted, and endocarditis was extensive.Inspiris valve size 27 was ultimately implanted instead, and the pacemaker was also removed.

• Brand Name: PERCEVAL PLUS 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
• MDR Report Key: 18361139
• MDR Text Key: 330933914
• Report Number: 3019892983-2023-01027
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270324
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023,12/19/2023

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: PVF-XL
• Device Catalogue Number: PVF-XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male