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

Model Number PVS21

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Aortic Regurgitation (1716)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Based on the initial information provided the device serial number is unknown and the device location is unknown.Without further information or the return of the device the manufacturer cannot perform any investigations and ultimately the root cause of the reported event cannot be established.The manufacturer will follow-up for further information and device return and will update the competent authority accordingly.Device disposition presently unknown.

Event Description

On (b)(6) 2019 a patient was intended to receive a perceval pvs21 sutureless aortic heart valve as part of the japan perceval heart valve study.The manufacturer was notified of an intra-operative serious adverse event - paravalvular leakage due to migration of the device.The site reported the device was explanted as a result of the issue.A new perceval pvs 21.

Manufacturer Narrative

This case is a duplicate of case # 2019-03655 (closed case) ref mw # 005683 (initial-june 14) and mw 006053 (fu-jul 24).Because this case is a duplicate, no further investigation or reporting will be provided.Please refer to mw # 005683 (initial-june 14) and mw 006053 (fu-jul 24).

• 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: 9498018
• MDR Text Key: 177994728
• Report Number: 3004478276-2019-00337
• Device Sequence Number: 1
• Product Code: LWR
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 49