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

Model Number	CNA21
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Low Cardiac Output (2501)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (b)(4).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.Device remains implanted.
Event or Problem Description
The manufacturer was informed on this event through the sure avr database.On (b)(6) 2016, a patient received a crown valve model cna21 through median sternotomy.During the same procedure, a mitral valve replacement and a tricuspid valve repair were also performed.The manufacturer was informed that on (b)(6) 2016, the following adverse event occurred: non structural dysfunction/paravalvular leak 3+.On (b)(6) 2016, a re-intervention (suture of the leak) was performed and the device was not explanted.The patient experienced also haemodynamic instability due to paravalvular leak/low cardiac output syndrome on (b)(6) 2016, reportedly resolved after the paravalvular leak was re-operated.The patient was discharged on (b)(6) 2016 with a good device functionality (mean gradient was 8mmhg, no perivalvular/central leak).Per additional information received, there are no reported factors related to the patient's anatomy or to the malfunction of the prosthesis that caused / contributed to the event of pvl.No other causes have been identified.Up to (b)(6) 2016, the postoperative course had initially been regular.On day (b)(6) 2016, the patient had complete atrioventricular block, dobutamine started with rhythm recovery.A respiratory and haemodynamic decline (probable pulmonary edema) subsequently took place on (b)(6) 2016, with the need for adrenaline infusion followed by an ultrasound diagnosis.The last echocardiogram available dates back to 2016 after the correction of the leak and from what was available there were no further cardiovascular events.
Additional Manufacturer Narrative
Based on the medical judgment received at the time of follow up, the root cause of the perivalvular leak was not traced to a malfunction of the prosthesis.Furthermore, the device was not explanted at the time of the re-intervention (suture of the leak), and a good functionality was reported at discharge with no further cardiovascular events reported afterwards.As such, based on the information available, the root cause of the reported event can be reasonably traced to the procedure and not to the device.

• 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
• MDR Report Key: 11211097
• Report Number: 3004478276-2021-00118
• Device Sequence Number: 17017782
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)210228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 60