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

Model Number	DLA23
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Occlusion (1984); No Information (3190)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is part of capa (b)(4) events identified as a possible complaint related to valve re-intervention.No further event details were provided.This case will be reported to fda in a conservative way, and no possible investigation will be performed at this time.Device not available for return.
Event or Problem Description
Based on capa (b)(4) investigation: this event refers to mitroflow valve dla21, implanted on (b)(6) 2016 and explanted the following day.A similar device but different size mitroflow dla23 was ultimately implanted instead on (b)(6) 2016.No further event details were provided.
Additional Manufacturer Narrative
Based on the new information gathered from the site, the device was explanted due to coronary ostium obstruction.The event is attributable to the surgical procedure and user error, and was resolved by using a smaller device.As the event was attributable to the procedure and not to the device, no further investigation is warranted at this time.
Event or Problem Description
A mitroflow dla23 was implanted on (b)(6) 2016 via median sternotomy.However, it was reported that the valve caused obstruction of the coronary ostium.The valve was explanted and replaced with a smaller mitroflow dla21.The new implanted device was functioning well upon discharge and during the 2 follow-up visits in 2017 and 2018.

• 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: 8318656
• Report Number: 3004478276-2019-00125
• Device Sequence Number: 16181606
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)180331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: No Information
• Device Expiration Date: 03/31/2018
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 69