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

Model Number	CNA21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received the device and performed a gross inspection.The device was received in generally good conditions with no anomalies observed.
Event or Problem Description
On (b)(6) 2018 a patient received an aortic valve replacement to replace am edwards magna 19mm ascending aortic valve implant.It was replaced with a crown prt cna21 due to an issue with valve functionality caused by adhered pannus.It was a biscuspid valve case.After implanting the valve a transvalvular leak was observed during re-circulation.A re-operation was scheduled for 2 days later.On (b)(6) 2018 the crown prt cna21 was explanted and replaced with a sjm regent mechanical valve.The patient was discharged and the outcome was reported as good.
Additional Manufacturer Narrative
Please note the manufacturer is re-submitting this medwatch due to a system error.The original report was submitted on sep, 6, 2018.In addition to the re-submission further investigation results and a conclusion have been added to this report based on results received on aug 10, 2018.The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, 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 crown prt aortic pericardial heart valve at the time of manufacture and release.A hydrodynamic test was performed to verify the devices functionality in operating conditions.The effective orifice area (eoa) at 70 bpm, 5 l/min of cardiac output and back pressure of 80 mmhg (around 100 mmhg mean aortic pressure) is 1.61 cm2, well above the iso 5840 minimum requirement 1.05 cm2.For a cardiac output of 5.0 l/min and back pressure of 80 mmhg (around 100 mmhg mean aortic pressure), even if a negligible hole is visible in closure phase, the regurgitant fraction [%] is 3.1% and it is well below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.The results of the analyzed crown prt valve size 21, sn 428319, show that the device totally meets the iso 5840 minimum requirements.After decontamination, a visual inspection was performed to evaluate the presence of elements of non-conformity: no anomalies were observed.Based on the performed analysis, it is reasonably possible to exclude any relationship between the reported event and the quality of the returned valve; the observed issue cannot be explained by any factor intrinsic in the involved device.The root cause of the event cannot be established at this time.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7708694
• Report Number: 3004478276-2018-00249
• Device Sequence Number: 13678934
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)210131
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/21/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention