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

Model Number	PVF-XL
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of this event through device tracking department.Based on the information on patient implant form, patient has received two perceval plus aortic valves (pvf-l and pvf-xl) on (b)(6) 2024.Based on the further information received, pvf-l was implanted in the patient and pvf-xl was not used.No further information is available at this time.

• Brand Name: PERCEVAL PLUS SUTURELESS AORTIC 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: 20080008
• Report Number: 3019892983-2024-01012
• Device Sequence Number: 18032817
• Product Code: LWR
• UDI-Device Identifier: 00896208000825
• UDI-Public: (01)00896208000825(240)PVF-XL(17)280217
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024
• Report Date (Section F): 07/29/2024

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• 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: 87 YR
• Patient Sex: Male