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

Model Number	CNA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Fever (1858); Thrombosis (2100)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note this device was implanted in a (b)(6) patient.A biological valve was originally chosen by the patient after being presented with the option of biological or mechanical option.As per crown prt ifu-warning and precautions "clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves." device not yet returned to manufacturer.
Event or Problem Description
On (b)(6) the manufacturer was notified of the following event: a crown prt pericardial heart valve size 25mm that was implanted on (b)(6) 2017 was explanted on (b)(6) 2017 due to thrombosis.Prior to explant the patient presented with fever, clots in legs and shortness of breath.Patient medication included eloquis then aspirin.The patient was of normal body habitus as per physician.All blood cultures performed were (b)(6) and there was no evidence of endocarditis.After explant of the crown device a carbomedics top hat mechanical heart valve size (b)(6) was then implanted.The patient is on ecmo at present.
Additional Manufacturer Narrative
The partial manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna25, s/n #(b)(4), were pulled and reviewed by quality engineering at livanova (b)(4) 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.Visual examination of the returned valve revealed damage to the prosthesis including a leaflet tear and cuts related to the surgical procedure.The leaflet tear likely caused a minor degree of insufficiency, and some thrombus deposition.X-ray analysis showed no calcification of the valve.Histological analysis revealed the presence of inflammatory cells, thrombus depositions, and gram-positive bacteria inside the pericardium, indicating the onset of infective endocarditis in the acute phase.The investigations performed revealed the absence of structural valve deterioration or other indicators of valve failure.The thrombus formation requiring valve explant is therefore likely attributable to infection and patient factors, although limited patient information was available.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7007036
• Report Number: 3004478276-2017-00183
• Device Sequence Number: 11163124
• Product Code: LWR
• UDI-Device Identifier: 00896208000535
• UDI-Public: (01)00896208000535(240)CNA25(17)190831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2017

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: 08/31/2019
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/23/2017; 11/30/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/12/2017; 12/22/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 48 YR