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

Model Number	CNA23
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Death (1802); Endocarditis (1834); Sepsis (2067)
Date of Event	08/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Not explanted - no autopsy performed.
Event or Problem Description
A mitroflow valsalva conduit and crown cna23 were implanted on (b)(6) 2018.On (b)(6), 2018, the patient experienced endocarditis.On (b)(6) 2018, the patient died of sepsis.The functionality of the valve at implant and discharge were not reported.However, it was indicated that there was no central or paravalvular leak at the time of implant.
Additional Manufacturer Narrative
Based on the physician's judgement, there is no link between the patient's endocarditis and the device, and therefore no link between the device and the patient's sepsis and death.The event is not valve-relate and no further investigation is warranted.Updated fields: not available for return.
Event or Problem Description
A mitroflow valsalva conduit and crown cna23 were implanted on (b)(6) 2018 as part of a bentall procedure.On (b)(6) 2018, the patient experienced endocarditis.On (b)(6) 2018, the patient died of sepsis.The death was classified as non-cardiovascular.It was reported that blood cultures were performed but were negative, and triple antibiotic therapy was administered.The patient presented with lumbar pain, but no fever.The physician reported that the valve was functioning well prior the event, and that there was no relationship between the patient's endocarditis and 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 V5J5M 1; CA V5J5M1
• MDR Report Key: 8005747
• Report Number: 3004478276-2018-00316
• Device Sequence Number: 16215535
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)221030
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: 79 YR
• Patient Weight: 104