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

Model Number PVS23

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/23/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a perceval valve pvs23 was implanted as part of an avr procedure.A concomitant cabg procedure was also performed.The ascending aorta dimension was 4.6 but had a nice waist at stj, deemed appropriate for the perceval valve given the annulus size.The valve deployment was performed uneventfully and the sinuses held saline without pvl after balloon.Good position was confirmed.The crossclamp was removed and the lv dilated severely.Wide open aortic insufficiency central was noted on the tee.The valve explanted and inspected.It was thought one leaflet looked less redundant than the other 2.A size 21 inspiris placed instead and patient is doing well.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 11874341
• MDR Text Key: 252323900
• Report Number: 1718850-2021-01082
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230610
• 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: 04/26/2021,05/24/2021

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 Expiration Date: 06/10/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2021
• Date Device Manufactured: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention