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

Model Number	CNA19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is presently following up to determine the details of this event.When additional information has been received, appropriate investigative actions will be taken.
Event or Problem Description
A crown prt pericardial heart valve was implanted on (b)(6) 2015.Device was explanted on (b)(6) 2018 and was replaced by perceval s.
Additional Manufacturer Narrative
Based on the size of the replacement device (b)(4) provided in the event narrative, it is possible that mis-sizing contributed to the reported event.
Event or Problem Description
A crown prt pericardial heart valve was implanted on (b)(6) 2015.Device was explanted due to structural valve deterioration on (b)(6) 2018 and was replaced by perceval s.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, (b)(4), as they pertain to the reported event, were retrieved and reviewed.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.Radiographic analysis of the valve showed the presence of intrinsic calcification in all the leaflets.Histo-morphological review confirmed the presence of valve stenosis due to intrinsic and vegetating calcifications on all three leaflets.A 7 mm tear was identified on one leaflet.The stent and sewing ring were covered by fibrous pannus that protruded 2-4 mm into the lumen, contributing to valve stenosis.The pericardium of all three leaflets were thickened due to calcification.Small thrombus depositions and blood entrapment were identified on the leaflets.Focal gram + bacteria and some inflammatory cells were also identified.Based on the analyses performed, the reported structural valve deterioration was confirmed.Leaflet calcification caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis, and the observed tear may have contributed to aortic insufficiency.Structural valve deterioration is the major cause of failure in bioprosthetic heart valves, and the principle underlying pathologic process is cuspal calcification.It is possible that the patient's clinical conditions and risk factors contributed to the structural valve deterioration observed in this valve; however, as the patient's clinical history was not available the root cause of this event ultimately cannot be determined.

• 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: 7252362
• Report Number: 3004478276-2018-00126
• Device Sequence Number: 1090595
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)190831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2018

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: 08/31/2019
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 02/12/2018; 03/22/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/11/2018; 03/22/2018
• 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: Required Intervention
• Patient Age: 81 YR