MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number	LXA
Medical Device Problem Codes	Calcified (1077); Material Deformation (2976)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)
Date of Event	08/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified on (b)(6) 2016 that a mitroflow valve (lxa21, s/n (b)(4)) was explanted after 2 years due to insufficiency and stenosis.
Additional Manufacturer Narrative
Mar 27, 2017 design history review: the complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model lxa21, s/n (b)(4), were pulled and reviewed by quality control at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model lx) mitroflow aortic pericardial heart valve at the time of manufacture and release.On sep 29, 2016: histological analyses were performed on samples taken from leaflets b and c.In leaflets b and c, alizarin red s stain showed the presence of intrinsic and-or vegetating calcifications.In leaflets b and c, hematoxylin and eosin stain showed that the collagen bundles were disrupted and deeply homogenated mostly under both surfaces.Inflammatory cells were present on leaflet c.Bacteria were not detected with the gram stain.
Additional Manufacturer Narrative
Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from leaflet tear.There was no evidence of endocarditis in the returned valve.As reported in the scientific literature, structural dysfunction is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical conditions and risk factors (aortic insufficiency and aortic valve stenosis ) may have contributed to the structural valve deterioration observed in this mitroflow valve.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 5973462
• Report Number: 3004478276-2016-00097
• Device Sequence Number: 10990834
• Product Code: DYE
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)190131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2017

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: 01/31/2019
• Device Model Number: LXA
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 04/06/2017; 05/16/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 80