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

Model Number	CNA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	05/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded by the hospital and is not available for further testing.The complete manufacturing and material records for the crown prt aortic pericardial heart valve, cna19(sn# (b)(4)), was pulled and reviewed by quality control at (b)(4).The results confirmed that each manufacturing and inspection operations were followed and this valve satisfied all material, visual, and performance standards required for crown prt aortic pericardial heart valve at the time of manufacture and release.Valve sterility log for the subject valve was pulled and reviewed by microbiology department at (b)(4) and results confirmed that valve met all requirements for sterility release.
Event or Problem Description
The manufacturer was notified on 19 june 2016 that crown prt cna19 was explanted due to infectious endocarditis.The crown prt, cna 19 was implanted on (b)(6) 2016 which was performed along with mitral valve replacement and tricuspid annuloplasty.The bacterium identified as staphylococcus epidermidis.

• 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: 5800663
• Report Number: 3004478276-2016-00070
• Device Sequence Number: 456772
• Product Code: DYE
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)170630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060038/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2016

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: 06/30/2017
• Device Model Number: CNA
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2016
• Initial Report FDA Received Date: 07/16/2016
• 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: Required Intervention
• Patient Age: 79 YR