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

Model Number	LXA21
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received for analysis on february 21, 2018.The returned prosthesis was received in generally good condition, with visible calcification on the posts of the valve.The manufacturer is in the process of attempting to obtain further information about this event.
Event or Problem Description
It was reported that a mitroflow valve was explanted after 4.5 years with significant structural valve deterioration.No further information was provided.
Event or Problem Description
It was reported that a mitroflow valve was explanted after 4.5 years with significant structural valve deterioration.No significant cardiac risk factors were reported.The patient's coronary arteries were reportedly normal.
Additional Manufacturer Narrative
Leaflet calcification was detected with visual, x-ray and histological analysis.Visual inspection revealed the presence of tears near the posts on two leaflets.Histological analysis also showed the presence of lipid infiltration (cholesterol clefts) in the pericardial tissue.Inflammatory cells were identified on the leaflets.There was no evidence of endocarditis on the valve, as evaluated with gram staining.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), as they pertain to the reported event, were pulled and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa21 mitroflow aortic pericardial heart valve at the time of manufacture and release.Based on the investigations performed, leaflet calcification caused stiffening of the leaflets and led to progressive valve stenosis.Lipid infiltration may have contributed to localized leaflet stiffness.Aortic insufficiency likely resulted from leaflet tearing.Although no risk factors for svd were reported, limited information about the patient's clinical history is known.It is therefore possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this mitroflow valve.However, the root cause of the event is ultimately unknown.

• Brand Name: MITROFLOW LXA
• 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: 7320750
• Report Number: 3004478276-2018-00144
• Device Sequence Number: 151110
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)180331
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 03/31/2018
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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