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

Model Number	DLA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Endocarditis (1834)
Date of Event	12/01/2018
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2015 a patient received a mitroflow dla21 as part of the (b)(6) trial.The manufacturer was notified of a serious adverse event, cardiovascular mortality - endocarditis, which occurred on (b)(6) 2018.The patient had three follow-ups prior to the reported adverse event.Fu 1: (b)(6) 2016, rhythm sinus, nyha class i, mean gradient 7 mmhg, good valve functionality.Fu 2: (b)(6) 2017, a-fib, nyha class i, mean gradient 15 mmhg, good valve functionality.Fu 3: (b)(6) 2018, a-fib, nyha class ii, mean gradient 29 mmhg.No further information regarding the patient or the event was recorded or received.
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.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 9079946
• Report Number: 1718850-2019-01085
• Device Sequence Number: 2976303
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)190731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019
• Report Date (Section F): 09/09/2019

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: 07/31/2019
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2019
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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: Death
• Patient Age: 80 YR
• Patient Weight: 76