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

Model Number PVS25

Device Problem Leak/Splash (1354)

Patient Problem Aortic Insufficiency (1715)

Event Date 10/01/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 a patient was status post endocarditis, needing his aortic valve replaced.After dr.(b)(6) made incision (aortotomy) he discovered the patient might have evolving endocarditis and sent off the valve leaflets to pathology for confirmation one way or the other.It was determined by dr.(b)(6) and dr (b)(6) after sizing correctly to implant a large perceval valve into this patient.Because of the endocarditis dr (b)(6) was concerned about the annulus not looking normal more especially on the right coronary cusp area.The valve was deployed in the usual manner per the ifu's and both dr.(b)(6) and dr (b)(6) were pleased with the implant.The checks were completed the valve was balloon dilated followed by another round of checks the guiding sutures were removed and the aortotomy was closed.As the patient was being weaned from bypass a pvl was noted on the right side of the valve.Because of where the pvl was located and the area of said leak not having any real annular plane to speak of it was decided both by dr.(b)(6) and dr.(b)(6) to replace the valve with a sewn in valve.The re-clamping of the aorta extending the procedure by an additional 79 minutes, while the original time was 73 minutes for a total time of 196 minutes of pump time.

Manufacturer Narrative

Several attempts have been made to fu for further information and no additional details have been provided at this time.Because no further information is available and the device has not been returned no further investigations can be performed.Based on the information provided the suspected root cause of the event is procedural complications due to the patient anatomy associated with previous endocarditis and a lack of annular plane leading to a paravalvular leak.However, at this time because there is no further information available and the device could not be returned the exact root cause of the event could not be established.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 9258326
• MDR Text Key: 176128441
• Report Number: 1718850-2019-01153
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)220420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR