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

Model Number	CNA25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	05/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.No autopsy.
Event or Problem Description
On (b)(6) 2015 a patient received a mitroflow dla25 aortic heart valve implant as part of the sure-avr trial via median sternotomy.A concomitant cabg was performed.The manufacture was notified of a serious adverse event.On (b)(6) 2015 the patient died from cardiovascular mortality / all valve-related deaths / endocarditis.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna25, s/n # (b)(6) , 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.If an infectious microorganism was present on the tissue valve before sterilization, it would be killed very easily by the manufacturers liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde, formaldehyde and alcohol, all of which are highly effective against infectious microorganisms.The manufacturer has validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.In addition, the sterile packaging solution used for shipment of mitroflow valves is a 4% formaldehyde solution; the valves remain in this extremely antimicrobial solution until they are opened during surgery.Therefore, it is not conceivable that an infectious microorganism could survive on a valve exposed to the manufacturers sterilant, or the packaging solution.The manufacturer has made several attempts to follow-up for additional information and has not received any follow-up.Given the information presently available, and because the device is not available for return, no additional investigations can be performed.Based on the verification of device sterilization there is no sufficient evidence reasonably suggesting the valve in question was related to the reported endocarditis and the likely cause of the event can reasonably be attributed to patient factors.However, at this time the exact root cause of the reported endocarditis cannot be determined.If additional information is received the manufacturer will reassess the investigation.
Additional Manufacturer Narrative
The device involved was originally reported as a mitroflow dla25.During the review of the device history records it was determined this was reported incorrectly.The device involved was a crown prt aortic pericardial heart valve cna25.This information has been corrected in an updated event description in section b5, as well as the device information in section d4.This information does not change the previously reported conclusion as the sterilization method for the crown prt is the same as the mitroflow device.
Event or Problem Description
On (b)(6) 2015 a patient received a crown prt cna25 aortic heart valve implant as part of the sure-avr trial via median sternotomy.A concomitant cabg was performed.The manufacture was notified of a serious adverse event.On (b)(6) 2015 the patient died from cardiovascular mortality / all valve-related deaths / endocarditis.

• 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: 8113674
• Report Number: 3004478276-2018-00352
• Device Sequence Number: 19236561
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)191130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2019

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: 11/30/2019
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 02/15/2019; 02/15/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 02/15/2019; 02/15/2019
• 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: Death
• Patient Age: 82 YR
• Patient Weight: 100