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

Model Number	DLA25
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Congestive Heart Failure (1783); Heart Failure (2206)
Date of Event	01/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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 dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The two reported serious adverse events were deemed not valve related by the mitroflow-pas clinical registry.However, upon review of the clinical history of the patient there was a gradient increase recorded during follow-ups prior to the heart failure.Based on this information it is not possible to completely exclude the valve as a contributing factor to the adverse events.Because the valve was not explanted and no further information is available the root cause of the event cannot be determined at this time.If further information is received the case will be reanalyzed.Device not explanted.
Event or Problem Description
On (b)(6) 2016 a mitroflow dla25 was implanted as part of the mitroflow-pas study.On (b)(6) 2018 the manufacturer was notified of two serious adverse events via the mitroflow-pas clinical registry.The patient was reported to have congestive heart failure on (b)(6) 2018 and heart failure on (b)(6) 2018.Upon further review of the patient history it was recorded that the patient suffered an ischemic stroke (b)(6) 2017.This is a non-device related issue.

• Brand Name: MITROFLOW DLA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7493057
• Report Number: 3004478276-2018-00184
• Device Sequence Number: 16478530
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: 02/28/2018
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/07/2018
• 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: Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Weight: 73