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

Model Number PVF-M

Device Problem Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, a perceval plus valve size m was attempted to be implanted.As reported, after collapsing the valve and implanting the valve, asymmetrical opening of the leaflets was noted.Reportedly, leaflets were not coapting well.As such, the valve was explanted, collapsed and implanted again.However, even after 3 attempts the issue was still existed.Ultimately, they decided to implant avalus valve instead.Based on the further information received, no malfunction was noted with the device prior to this event, patient remained stable through the prolongation of surgery.Reportedly, there was no abnormality in the patient's annulus geometry.

• 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
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 19169535
• MDR Text Key: 340897777
• Report Number: 3005687633-2024-00106
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 08022057015372
• UDI-Public: (01)08022057015372(240)PVF-M(17)271122
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: PVF-M
• Device Catalogue Number: PVF-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 72 KG