MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW 12A; TISSUE HEART VALVE

Model Number 12A19

Device Problem Gradient Increase (1270)

Patient Problem Valvular Stenosis (2697)

Event Type  Injury  

Manufacturer Narrative

According to the physician, the patient¿s medication (prednisolone) could contribute to this early valve dysfunction, because this medicine is a strong anti-inflammatory agent and thrombosis is known as one of adverse effects with a long-term administration.However, at this point there is no indication of valve failure specifically due to thrombosis, so the relationship of the event to the patient's medication remains unknown.The manufacturer was notified that further information, such as the patient's medical history, is not available for this case.Device not explanted.

Event Description

On (b)(6) 2014, a mitroflow valve was implanted due to stenosis and increased pressure gradient.The patient also exhibited aortitis.A bentall operation was performed, and the mitroflow valve was implanted.In (b)(6) 2017, mitroflow valve stenosis was reported to have rapidly progressed within the previous 6 months, and increased pressure gradient was observed.A valve-in-valve procedure was performed.No further information was available at the time of reporting this event.

Event Description

Manufacturer received additional information on (b)(6) 2018 that poor leaflet movement was observed in one leaflet on echo observation.The patient had been taking steroid drug, but it is unknown if this drug could contribute to aortic stenosis.This patient fainted twice, but the detail cause is unknown.

• Brand Name: MITROFLOW 12A
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7197210
• MDR Text Key: 97439152
• Report Number: 3004478276-2018-00115
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000016
• UDI-Public: (01)00896208000016(240)12A19(17)190630
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: 12A19
• Device Catalogue Number: 12A19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention