MAUDE Adverse Event Report: LIVANOVA CANADA CORP PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Device Problem Material Deformation (2976)

Patient Problems Syncope (1610); Death (1802)

Event Type  Injury  

Manufacturer Narrative

Device not available for return.

Event Description

A percival valve was implanted on (b)(6) 2014.Approximately 4.5 years post-implant the patient presented with syncope, and echocardiography revealed svd of the valve.Due to increasing severity of the patient's syncope, emergency re-operation was scheduled.At the time of the procedure, the patient went into cardiac arrest prior to cannulation.Cpr was performed, and it reportedly took 5 minutes to cannulate the patient.The percival valve was explanted and replaced with a perimount valve, and concomitant double bypass was performed.At the end of the operation, it was not possible to wean the patient from bypass, and the decision was made not to place the patient on ecmo.The patient died in the operating room.

Manufacturer Narrative

Based on the information received, the patient had pre-existing coronary artery disease and underwent concomitant double bypass surgery at the time of reoperation.It is therefore likely that the patient's cardiac arrest and subsequent death are related to the patient's underlying clinical condition, rather than directly related to the device.However, this cannot be confirmed from the limited information provided.The relationship between the patient's death and the reported svd therefore remains unknown.As the device was not received for analysis and the serial number of the device is unknown, no device investigation can be performed and the root cause of the svd cannot be determined.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8329483
• MDR Text Key: 135842697
• Report Number: 3005687633-2019-00121
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 79 YR