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

Model Number	CNA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on (b)(6) 2016 that a crown valve implanted on (b)(6) 2016 was explanted after 1 month due to endocarditis.The event as follow: on (b)(6) 2016 - crown prt was implanted in the patient.The patient discharged 2 weeks after the implantation.Around mid-november - the patient visited the hospital due to having fever.Infectious endocarditis was confirmed, and infectious bacterium identified by the institute was staphylococcus.On (b)(6) 2016 - the valve replacement was performed with reinforcing the valve ring with a patch.This crown prt valve was explanted and valve from another manufacturer was implanted.
Additional Manufacturer Narrative
The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model cna19, s/n (b)(4), were pulled and reviewed by quality control at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a cna19 mitroflow aortic pericardial heart valve at the time of manufacture and release.This mitroflow valve was explanted after 1 month due to a reported prosthetic endocarditis.Gross examination revealed a slightly stenotic bioprosthesis due to large thrombotic depositions on both sides of all leaflets.Histological analysis revealed inflammatory cells and gram-positive bacteria spread inside the thrombus depositions and in the pericardium.The presence of thrombus depositions, inflammatory cells, and bacteria colonies indicated the onset of an infective endocarditis in the acute phase.It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this mitroflow valve.However, little clinical history was provided.
Additional Manufacturer Narrative
Narrative corrected: the complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model cna19, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a cna19 mitroflow aortic pericardial heart valve at the time of manufacture and release.This mitroflow valve was explanted after 1 month due to a reported prosthetic endocarditis.Gross examination revealed a slightly stenotic bioprosthesis due to large thrombotic depositions on both sides of all leaflets.Histological analysis revealed inflammatory cells and gram-positive bacteria spread inside the thrombus depositions and in the pericardium.The presence of thrombus depositions, inflammatory cells, and bacteria colonies indicated the onset of an infective endocarditis in the acute phase.

• 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: 6182977
• Report Number: 3004478276-2016-00173
• Device Sequence Number: 551824
• Product Code: DYE
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)170930
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2017

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: 09/30/2017
• Device Model Number: CNA
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided; 11/09/2017
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 05/17/2017; 11/09/2017
• 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