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

Model Number	CNA27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
On (b)(6) 2016 a mitroflow valsalva conduit mvc032 and crown cna27 valve was implanted as part of the sure-avr trial.On (b)(6) 2017 a serious adverse event occurred.The patient had endocarditis.This was reported as the primary onset and the microorganism is unknown.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna27, 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.According to the data filed in the registry, the patient had central leak 1+ at discharge.However, at follow up in 2018, 9 months after the event, zero central or paravalvular leak were identified.The patient's gradients were not provided.Based on the available information, and given that the valve remains implanted, there is no evidence of valve dysfunction.As the device was not explanted, no further investigation can be performed at this time.Based on the document review performed, no manufacturing deficits were identified.Given that the event occurred remote from the time of implant and there was no evidence of valve dysfunction in the patient's follow-up records, the event is unlikely to be related to the device and more likely to be related to the patient's clinical condition.However, as the device was not available for return, no device analysis could be performed and the root cause of the event ultimately cannot be determined.

• 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: 7648957
• Report Number: 3004478276-2018-00230
• Device Sequence Number: 1146275
• Product Code: LWR
• UDI-Device Identifier: 00896208000542
• UDI-Public: (01)00896208000542(240)CNA27(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: Physician
• Device Expiration Date: 08/31/2020
• Device Model Number: CNA27
• Device Catalogue Number: CNA27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: Disability
• Patient Age: 67 YR
• Patient Weight: 125