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.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer's quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1209) perceval heart valve at the time of manufacture and release.The documentation included the steady flow test performed at the time of valve release.This review confirmed an acceptable opened and closed leaflet performance of the perceval pvs23 sn# a97452.No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in principal device function test at the time of release.Since the device was not returned to the manufacturer no further investigation was possible at this time.Based on the available information, it is not possible to draw a definitive conclusion for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Considering the labelled dimensions of the perceval valve pvs23 (id 21-23mm) and the ones of the inspiris size 21 (id 20mm), a slight oversizing may have occurred.However, this was not confirmed based on the information received (i.E.''the ascending aorta dimension was 4.6 but had a nice waist at stj, deemed appropriate for the perceval valve given the annulus size'').Ultimately, given that the device was not returned and no further information was provided despite the attempts of follow up, the root cause remains unknown at this time.Although the device was initially made available for return, it was not received after more than 90 days.As such, no further investigation is possible.Should the device be returned at a later stage, or should further information become available in the future, the manufacturer will provide an update to this reporting activity.

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11874348
• MDR Text Key: 252317465
• Report Number: 3004478276-2021-00161
• 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
• 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,Followup
• Report Date: 01/21/2022

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
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 12/31/2021
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• 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