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

Model Number 12A25

Device Problem Degraded (1153)

Patient Problems Endocarditis (1834); Multiple Organ Failure (3261)

Event Date 10/16/2019

Event Type  Death  

Manufacturer Narrative

Unknown disposition.

Event Description

On (b)(6) 2006 a patient received a mitroflow 12a25 as part of an avr.The manufacturer was notified that the device was explanted on (b)(6) 2019 as a result of endocarditis and a failing bioprosthetic.A carbomedics s5-027 was implanted as a replacement.The manufacturer received information from the site identifying that the patient was scheduled for re-operation due to valve failure prior to the identification of the prosthetic infection.The patient received the mitroflow in 2006 as a result of endocarditis of the native valve.Upon inspection of the valve during re-operation the left coronary cusp was affected by acute infection, and there was an annular abscess.The was bioprosthetic deterioration with mixed as and ai.There were no other valve malfunctions present.The patient died soon after surgery from multisystem failure from reoperative surgery.There was no relationship to the new valve.The patient had a failing mitroflow and the site started planning for redo surgery, but then the patient developed prosthetic valve endocarditis.No further details are available and the device is not available for return and analysis.

Manufacturer Narrative

The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # 12a25, s/n # (b)(6) , 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 12a25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The dhr review confirmed the device met all required sterilization standards at the time of manufacture and release.Since the valve is not available for anlaysis, no further investigation can be performed at this time.It is possible that the patient's risk factors contributed to the reported structural valve deterioration.However, since no investigation could be performed and no information on the patient risk factors is available, this cannot be ultimately confirmed.Structural valve deterioration is listed as a possible adverse event in the perceval ifu.Given the information provided it is not possible to determine the relationship between the prosthetic infection and valve deterioration.In addition the timeline between the two events is unknown given the information available.At this time the root cause of the event cannot be established.Fields changed: b4, g4, g7, h2, h6.

• 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: 10248881
• MDR Text Key: 198069476
• Report Number: 3004478276-2020-00167
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000047
• UDI-Public: (01)00896208000047(240)12A25(17)110228
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: 12A25
• Device Catalogue Number: 12A25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR