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

Model Number	DLA25
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Corneal Pannus (1447); Aortic Valve Stenosis (1717); Thrombus (2101)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information is being requested by the manufacturer.Visual examination was performed on the returned device on (b)(6) 2018.The returned valve was received with a piece detached and traces of pannus on the sewing cuff, in particular on the outflow side.Calcifications on the leaflet were visible.Further evaluation is being performed by the manufacturer and will be reported in the follow up report.
Event or Problem Description
Manufacturer was notified that patient who had mitroflow dla valve implanted on (b)(6) 2016 underwent aortic valve replacement on (b)(6) 2018 and the device was replaced with mechanical valve.
Event or Problem Description
Manufacturer was notified that patient who had mitroflow dla 25 mm valve implanted on (b)(6) 2016 underwent aortic valve replacement on (b)(6) 2018, due to stenosis.The valve leaflets were reportedly thickened and rigid.The device was replaced with a st.Jude regent 23 mm mechanical valve, and the patient outcome was good.
Additional Manufacturer Narrative
Radiographic review of the returned device confirmed the presence of intrinsic calcification in all of the leaflets.Hystopathologic analysis confirmed the presence of pannus over the free edges of both leaflets surrounding one of the valve posts, which contributed to the observed stenosis of the valve.All leaflets were stiffened due to intrinsic and vegetating calcifications.Small thrombus depositions were visible on the inflow surfaces.Gram staining showed some focal gram positive bacteria.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla25, s/n # (b)(4), as they pertain to the reported event, were pulled 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 dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.As reported among the contraindications in the mitroflow dla instructions for use, patients "who are 55 years of age or less may have an increased tendency toward calcification of valvular bioprostheses." as such, the patient's age ((b)(6)) was a risk factor for early structural valve deterioration, and a contraindication for use of the mitroflow dla, and thus may have contributed to the reported failure of this device.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PRT
• 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: 7268657
• Report Number: 3004478276-2018-00127
• Device Sequence Number: 11126635
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)201113
• Combination Product (Y/N): N
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: 11/13/2020
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/14/2018
• Supplement Date Received by Manufacturer: 02/11/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/09/2018
• 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: 45 YR
• Patient Weight: 100