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

Model Number	DLA27
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Heart Failure (2206)
Date of Event	04/23/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event was reported to the manufacturer through the (b)(6) registry.Based on internal clinical assessment the event was determined to be unknown if valve related.Device not explanted.
Event or Problem Description
A mitroflow dla27 was implanted on (b)(6) 2017 via median-sternotomy.On (b)(6) 2017, the patient died of cardiovascular mortality due to unknown cause.
Additional Manufacturer Narrative
This event was reported to the manufacturer through the sure-avr registry.Based on internal clinical assessment the event was determined to be unknown if valve related.The event was therefore reported in a conservative manner.The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla27, s/n #(b)(4), were pulled and reviewed by quality engineering at livanova (b)(6) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla27 mitroflow aortic pericardial heart valve at the time of manufacture and release.As the device was not explanted, no device investigation could be performed.However, based on the document review conducted, no manufacturing deficits were identified.Furthermore, there is no evidence suggesting that the event was device-related, given that the cause of cardiovascular mortality was not identified.As such, the root cause of the event is unknown; however, the event is not clearly attributable to the device.Updated fields: (correction: additional patient code, additional information: device/methods/results/conclusions).

• Brand Name: MITROFLOW DLA
• 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: 7096891
• Report Number: 3004478276-2017-00200
• Device Sequence Number: 1378711
• Product Code: LWR
• UDI-Device Identifier: 00896208000191
• UDI-Public: (01)00896208000191(240)DLA27(17)190228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/03/2018

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: 02/28/2019
• Device Model Number: DLA27
• Device Catalogue Number: DLA27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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: Death