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

Model Number	DLA21
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted (tavi).
Event or Problem Description
A mitroflow dla21 was implanted on (b)(6) 2015.Three years post-implant, the patient is being referred for tavr, due to structural valve deterioration.No other information is available.The patient's clinical history remains unknown.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # (b)(4), as they pertain to the reported event, were retrieved 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 dla21 mitroflow aortic pericardial heart valve at the time of manufacture and release.Structural valve deterioration 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.It is possible that the patient's clinical condition and risk factors contributed to the reported event; however, as the patient's clinical history is unknown, this cannot be confirmed.As the device was not received for analysis, and limited information was provided, the root cause of the event ultimately cannot be determined.

• Brand Name: MITROFLOW DLA 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: 7715127
• Report Number: 3004478276-2018-00256
• Device Sequence Number: 903805
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)170131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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: 01/31/2017
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/24/2018
• 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: 72 YR