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

Model Number	PVF-XL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3019892983-2023-01027
• Device Sequence Number: 20757376
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)270324
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2023
• Report Date (Section F): 11/20/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male