MAUDE Adverse Event Report: LIVANOVA CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number CNA21

Device Problem Difficult to Open or Close (2921)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/17/2020

Event Type  Injury  

Event Description

The manufacturer received information on a patient, implanted with a crown prt valve, model cna21, on (b)(6) 2020 that was re-admitted to the hospital on (b)(6) with heart failure/aortic regurgitation.The transthoracic echocardiogram (toe) showed a leaflet dysfunction.Specifically, it was reported that there appears to be restricted motion of one of the valve cusps.There was no thrombus/pannus identified as root cause of the stuck leaflet.The patient was treated with valve in valve (tavi) on (b)(6) 2020 and the patient received 23mm medtronic evolut pro.As reported, in theatre on the toe that one leaflet was a bit strange but was mild aortic regurgitation at the time.

Manufacturer Narrative

The manufacturing and material records for the crown prt aortic pericardial heart valve, model#: cna21, s/n#: (b)(6) , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.A review of the function test (open/close valve) at the time of manufacture and release was also perform.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.The manufacturer attempted to retrieve additional information on the event, but no further details has been received to date.Since the device was not explanted, no further investigation is possible at this time.Based on the information available, it is not possible to draw a definitive conclusion on the reported event.However, per the document review performed, no manufacturing deficits have been identified.Should further information become available in the future, the manufacturer will provide an update to this reporting activity.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11270531
• MDR Text Key: 233294280
• Report Number: 1718850-2021-01011
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)210930
• 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: 01/04/2021,04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention