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

Model Number	LXA21
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device being sent to manufacturer.
Event or Problem Description
On (b)(6) 2014 a patient received a mitroflow lxa21 aortic heart valve.The manufacturer was notified the surgeon explanted the aortic valve after +/- 4.6 years, on (b)(6) 2019.Patient (male) was +/- 70 years of age when he received the first implant.Valve was replaced with a edwards perimount 23mm.
Event or Problem Description
The manufacturer received additional information on oct.23, 2019 identifying the patient outcome was fine.
Additional Manufacturer Narrative
The manufacturer received additional information on oct.23, 2019 identifying the patient outcome was fine.At this time the manufacturer has not received any further information from the site and the device has not been received for investigation.Thus the manufacturer cannot conduct any investigations related to the device.The manufacturer is continuing to follow-up for further information and will update the competent authority if any information is received.At this time the root cause cannot be established.Fields changed: b4, b5, g4, g7, h2, h6.
Additional Manufacturer Narrative
The manufacturer received the device for investigation on december 19th 2019.At this time the case was re-opened for investigation.A gross investigation was performed.The returned prosthesis was received with traces of pannus and calcification.X-rays of the subject valve showed intrinsic calcifications in leaflets a and b.Histological analyses were performed on samples taken from leaflets b and c.In leaflet b, alizarin red s stain showed the presence of small intrinsic and vegetating calcifications.In leaflets b and c, hematoxylin and eosin stain showed that the pericardium was thicker than normal because the collagen bundles were disrupted, defibrated and homogenated; because the collagen bundles showed a bubbly aspect and because cholesterol clefts were detected.Degenerated macrophages were present on leaflets b and c.Pericardial delaminations were detected on leaflet b.Bacteria were not detected with the gram stain.Investigation conclusion: 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 leaflets tears.There was no evidence of endocarditis in the returned valve.Structural dysfunction is a 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).Histological analysis showed the presence of lipid infiltration (cholesterol clefts) in the pericardial tissue.This lipid infiltration, may contribute to localized leaflet stiffness, and if associated with a degeneration of collagen fibers, as detected in the samples from this valve, may also lead to leaflet tearing.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.At this time the exact root cause of the reported calcification cannot be determined but this event is determined to be a known inherent risk of device.Fields changed: please note the manufacturer is submitting this report past the 30 day requirement for notification of the device return.This issue was an internal clerical error.

• Brand Name: MITROFLOW LXA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8919130
• Report Number: 3004478276-2019-00251
• Device Sequence Number: 1828792
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)180731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2020

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: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 12/19/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/20/2019; 01/24/2020
• 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: 75 YR
• Patient Weight: 88