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

Model Number	CNA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Death (1802)
Date of Event	12/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
It was reported that a patient returned to the hospital 6 months after a crown prt pericardial heart valve, size 25 mm, and mitroflow valsalva conduit 30mm were implanted.The tee showed limited opening of the valve.The patient died shortly after the tee.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.As no autopsy was performed, the device was not explanted and no further investigation can be performed.The manufacturer was unable to obtain any further information about this event.Based on the document review performed, no manufacturing deficits were identified.However, as the device was not received for analysis, no device investigation could be performed and the root cause of the event cannot be determined.No autopsy performed - not explanted.
Event or Problem Description
The manufacturer received confirmation on (b)(6) 2018 that no autopsy was performed, but was unable to obtain any further information about the event.

• 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 7180732
• Report Number: 3004478276-2018-00113
• Device Sequence Number: 16416597
• Product Code: LWR
• UDI-Device Identifier: 00896208000535
• UDI-Public: (01)00896208000535(240)CNA25(17)200131
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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: 01/31/2020
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/16/2018
• 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: Death
• Patient Age: 66 YR