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

Model Number PVS23

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problems Aortic Regurgitation (1716); No Information (3190)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

Device location not presently known.

Event Description

On (b)(6) 2019, a male patient received a pvs23 in aortic position.On (b)(6) 2019, the pvs23 was explanted and replaced with a pvs25.No other information is presently available.

Manufacturer Narrative

Based on the additional information received, the explant of the device was attributed to a non-structural dysfunction of the device, which appears to be 'rocking' in the aortic root.Since the device was not returned to the manufacturer, no device inspection can be performed at this time.However, given that a bigger size (i.E.Pvs25) was reportedly implanted, it is possible that the device was initially undersized thus contributing to the reported event.The manufacturer was informed on this event through the device tracking department.There has been no allegation of device malfunction or complaint by the site.If additional information will become available, a follow up report will be submitted.

Event Description

On (b)(6) 2019, a male patient received a pvs23 in aortic position.On (b)(6) 2019, the pvs23 was explanted and replaced with a pvs25.Per additional information received from the site, the implant of the pvs23 was completed successfully on (b)(6) 2019.The post-operative echo revealed a well-seated prosthesis, with no evidence of a paravalvular leak or intravalvular leaks.The gradient across the valve measure 16mmhg peak and 7mmhg mean.However, in the cardiac test performed on (b)(6) 2019, the valve was noted to be rocking within the aortic root.The valve leaflets are thickened and poorly visualized.There is at least moderate aortic valve regurgitation; the perivalvular leak is not confirmed due to the limiting quality of the study.A re-intervention occurred on (b)(6) 2019, in which the pvs23 was explanted and the pvs25 was implanted.The post-operative echo revealed a well-seated valve; there is a perivalvular leak noted with moderate insufficiency, and a mean gradient of 10mmhg.

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 quality engineering at livanova canada corp.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.Based on the review performed, no manufacturing deficits were identified.Based on the available information, given that a bigger size (i.E.Pvs25) was implanted after one week, it is possible that the device was initially undersized thus contributing to the reported event.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9182062
• MDR Text Key: 162487170
• Report Number: 3004478276-2019-00277
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)210208
• 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,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR