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

Model Number TBD

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Event Description

The manufacturer received information of a thrombosis on a perceval leaflet treated by antiplatelet aggregation agent.No further information is presently available.

Manufacturer Narrative

As the serial # is unknown and device is not available for return, the manufacturer is unable to conduct any further investigation at this time.The root cause of the event thus cannot be determined.If additional information is received the manufacturer will reassess the investigation at that time.

• 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: 10673916
• MDR Text Key: 211298460
• Report Number: 1718850-2020-01172
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/16/2020,02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other