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

Model Number PVS23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Device disposition presently unknown.

Event Description

On (b)(6) 2018 a patient received an aortic heart valve replacement.The manufacturer was notified that a pvs23 was implanted and explanted and a pvs21 was implanted.No additional information was received.

Manufacturer Narrative

On april 4, 2019 the manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(4), 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.The manufacturer was notified that no additional information from the site is available.Based on the original event information the device was intraoperatively changed from a pvs23 to a pvs21 which indicates a mis-sizing may have occurred, however at this time the root cause cannot be established as no further information is available.

• 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: 8187480
• MDR Text Key: 131135709
• Report Number: 3004478276-2018-00370
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)210314
• 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: 04/05/2019

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: 03/14/2021
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR