MAUDE Adverse Event Report: CARDIAC ASSIST INC. PROTEKDUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-5131

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Type  Injury  

Manufacturer Narrative

A1.-a6.No patient information was provided.D4.No serial number(s) has been provided, so udi and expiration date could not be determined.H4.As a serial number has not been provided, manufacture date is unknown.H10.Livanova manufactures the protekduo.The event occurred in (b)(6).Livanova has attempted to gather additional information about the event, including details of each event (e.G.Event date), the alleged relationship between the events and the livanova device, and other information about what has occurred.During a discussion with dr.Brewer, he indicated that specific details regarding this event (e.G.Event date, patient information, device information, etc.) were not recorded and could not be provided.During the follow-up communication, dr.Brewer indicated that severe tricuspid regurgitation was identified on a patient who suffered from rv disfunction prior to surgery, and the protekduo needed to be run at a higher rate in order to get septal balance.The customer did not know the valve condition prior to implantation and believes the device contributed to the regurgitation in some way.The patient was on support for 24-48 hours prior to the event and remained on the protekduo for 10-14 days following the event without any complications.At this time, there is no known malfunction of the protekduo that has been reported and it is unclear if any relationship exists between the reported adverse events and the livanova device.The customer believes the device contributed in some way, but no specific malfunction has been identified.As device information was not provided, a review of the dhr could not be performed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device(s) has not been made available.

Event Description

Livanova received a report from a physician who stated that they noticed a patient with severe pulmonic insufficiency after placing the protekduo 31fr cannula while on support for 24-28 hrs.The patient had the protekduo remain in place without any complications but had to run at a higher speed for 10-14 days.The patient was reportedly still in icu at the time the event was reported.

• Brand Name: PROTEKDUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC ASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIAC ASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 18114854
• MDR Text Key: 327883656
• Report Number: 2531527-2023-00036
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

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: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other