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

Model Number PVS23

Device Problems Collapse (1099); Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

Device disposed of by site.

Event Description

On (b)(6) 2019 a patient was intended to receive a perceval pvs23 sutureless aortic heart valve as part of an avr.The manufacturer was notified that the device was explanted intra-operatively due to a folding of the valve stent resulting in a paravalvular leak.The valve was replaced with a perceval pvs21 valve.No further incidents or issues occurred as a result of this intra-operative failure to implant.

Manufacturer Narrative

The manufacturer received additional information identifying the following.Valve oversizing was suspected as the cause of the stent folding.The patient was last seen on january 7th and has had an uncomplicated and uneventful recovery.A complete manufacturing and material records review for the component has been performed.The results confirmed that the component satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information received the event was a result of an intra-operative over-sizing and is not a result of any device related deficiency.The dhr review confirmed there were no issues with the device at the time of manufacture and release.The root cause of the reported intra-operative event is thus stent folding as a result of the over-sizing of the valve.Fields changed: b4, g4, g7, h2, h6.

Event Description

On (b)(6) 2019 a patient was intended to receive a perceval pvs23 sutureless aortic heart valve as part of an avr.The manufacturer was notified that the device was explanted intra-operatively due to a folding of the valve stent resulting in a paravalvular leak.The valve was replaced with a perceval pvs21 valve.No further incidents or issues occurred as a result of this intra-operative failure to implant.The manufacturer received additional information identifying the following.Valve oversizing was suspected as the cause of the stent folding.The patient was last seen on january 7th and has had an uncomplicated and uneventful recovery.

• 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: 9514238
• MDR Text Key: 174874896
• Report Number: 3004478276-2019-00342
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220212
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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: 02/12/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1