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

Model Number TBD

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Type  Injury  

Manufacturer Narrative

Unknown disposition.

Event Description

The manufacturer was notified that a patient received a perceval valve in (b)(6) 2019, which was explanted in (b)(6) 2019.Severe aortic regurgitation was identified prior to the re-intervention.

Manufacturer Narrative

The manufacturer attempted to retrieve additional information on the event, but no further information has been received to date despite the attempts.As the device was not returned for analysis and the serial number remains unknown, no further investigation is possible at this time.Based on the available information, the manufacturer is unable to establish a definitive conclusion for the reported event.The root cause of the explant and aortic regurgitation remain unknown at this time.Should further information be provided in the future, the manufacturer will re-assess the event and 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
• MDR Report Key: 10946869
• MDR Text Key: 219562695
• Report Number: 3004478276-2020-00241
• 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: 01/14/2021

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 Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR