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

Model Number	DLA25
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is considered a near adverse event and is being reported in a conservative manner.The patient is being monitored and follow-up is being conducted regarding the patient's present condition.Device not explanted.
Event or Problem Description
A mitroflow dla25 was implanted in a (b)(6) old male with a native bicuspid valve on (b)(6) 2015.The patient is very fit.A recent cardiology report states that the valve leaflets are not functioning properly due to aortic stenosis.The patient is being monitored and will have additional in-hospital tests conducted in a few weeks before explanting the valve.
Additional Manufacturer Narrative
Date received by manufacturer.Based on the additional information received, the valve is functioning normally and no device failure is suspect.As such, no further investigation will be performed at this time.
Event or Problem Description
A mitroflow dla25 was implanted in a (b)(6) male with a native bicuspid valve on (b)(6) 2015.The patient is very fit.A recent cardiology report states that the valve leaflets are not functioning properly due to aortic stenosis.The patient is being monitored and will have additional in-hospital tests conducted in a few weeks before explanting the valve.Additional information received on oct 24, 2017 indicated that the patient had another echo done and the valve function was deemed totally normal.No further action will be taken.

• Brand Name: MITROFLOW DLA
• 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: 6974511
• Report Number: 3004478276-2017-00173
• Device Sequence Number: 11062053
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: 08/31/2020
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/02/2017
• 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: Other
• Patient Age: 55 YR