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

Model Number	LXA27
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa27, s/n # (b)(4), as they pertain to the reported event, were retrieved 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 lxa27 mitroflow aortic pericardial heart valve at the time of manufacture and release.Gross examination of the returned valve revealed that the dacron surrounding the stent was partly removed due to the use of a cautery device.The leaflets of the valve were rigid, and organic material was present on one leaflet.Traces of pannus were visible on both the inflow and outflow sides of the valve.
Event or Problem Description
A mitroflow lxa27 was implanted on (b)(6) 2014.The valve was explanted approximately 4 years later.The reason for explant was not provided.
Additional Manufacturer Narrative
X-ray analysis of the returned device showed large intrinsic calcifications.Visual examination revealed pannus on the inflow side that protruded 2-3 mm into the lumen, narrowing the annulus.Reddish areas due to coagulated blood entrapment were visible on all surfaces.Whitish areas due to tissue alterations were visible on both prosthetic sides.Folds due to altered movement of the prosthesis were present in all leaflets.Small thrombus depositions were visible on the outflow side of one leaflet, and on all inflow surfaces.Histological analysis confirmed that the pericardium was thickened due to large intrinsic and vegetating calcifications.The collagen bundles were disrupted, defibrated and homogenated and showed a bubbly aspect.Cholesterol clefts were detected on one leaflet.Inflammatory cells were present on two leaflets.Bacteria was not detected with gram staining.There was no evidence of endocarditis.Based on the investigations performed, leaflet calcification and pannus overgrowth into the lumen contributed to valve stenosis.Histological analysis showed the present of lipid infiltration (cholesterol clefts) in the pericardial tissue.The lipid infiltration may contribute to localized leaflet stiffness.It is possible that the patient's clinical history and risk factors contributed to the cuspal calcification and stiffening observed in the valve; however, as limited clinical history was provided, this cannot be confirmed.As reported in the scientific literature, structural dysfunction is the major cause of bioprosthetic heart valve failure.As such, the reported event is a known inherent risk of the procedure.

• Brand Name: MITROFLOW LXA AORTIC 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: 7760172
• Report Number: 3004478276-2018-00272
• Device Sequence Number: 16592889
• Product Code: LWR
• UDI-Device Identifier: 00896208000139
• UDI-Public: (01)00896208000139(240)LXA27(17)140507
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: LXA27
• Device Catalogue Number: LXA27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 58 YR