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

Model Number UNKNOWN

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

At this time the manufacturer has been notified that the device is not available for return and the device serial number is presently unknown.Based on this information no investigations can be performed and the root cause of the reported event cannot be established.If further information is received the manufacturer will perform all available investigations.

Event Description

The manufacturer was notified of a device explant involving a mitroflow 12a aortic heart valve prosthesis.The device was explanted on (b)(6) 2019 as a result of structural valve deterioration leading to aortic stenosis.The leaflets were reportedly hardened and were not functioning correctly.The device was retained by the site and is not available for return.

Manufacturer Narrative

The manufacturer received the device implant date on (b)(6) 2020, and was notified no further information was available.The following updated event description has been entered in section b5.On (b)(6) 2014 a patient received a mitroflow lxa biological aortic valve implant as part of an avr.The manufacturer was notified the device was explanted on (b)(6) 2019 as a result of structural valve deterioration leading to aortic stenosis.The leaflets were reportedly hardened and were not functioning correctly.The device was retained by the site and is not available for return.The manufacturer received follow-up identifying no further information was available and that the site was not willing to provide results of the pathological test.Because the device serial number is unknown and the device is unavailable no further investigations are possible at this time.The manufacturer is unable to determine the root cause of the structural valve deterioration due to the lack of analysis possible.However, structural valve deterioration is a known inherent risk of device with biological valve implantation.Changed fields: b4, b5, g4, g7, h2, h6.

Event Description

On (b)(6) 2014 a patient received a mitroflow lxa biological aortic valve implant as part of an avr.The manufacturer was notified the device was explanted on (b)(6) 2019 as a result of structural valve deterioration leading to aortic stenosis.The leaflets were reportedly hardened and were not functioning correctly.The device was retained by the site and is not available for return.

• Brand Name: MITROFLOW 12A
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 9630471
• MDR Text Key: 177391056
• Report Number: 3004478276-2020-00111
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/26/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR