MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZC21A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Aortic Dissection (2491)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

An aortic dissection is a tear in the inner lining of the aorta.As a result, blood flows through this newly created false channel, which raises a flap that can occlude blood flow in the true lumen.This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention.There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention.As reported, the cannula suture ring was found to be loose.It was noted that the patient had aortic dissection, which may have been caused by the cannula slipping because the ring was not as secured as normal.In this case, the root cause cannot be conclusively determined with the available information.There has been no allegation of device malfunction.However, this event was likely due to procedural related factors.Per the instructions for use (ifu), "if suture ring assembly is required prior to aortic cannulation, remove suture ring from pouch and slide over cannula tip to desired location." additionally, "proper surgical procedures and techniques are the responsibility of the medical profession.Described procedures are provided for informational purposes only.Each physician must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use." the subject device is not available for evaluation.The device history record (dhr) was not reviewed as the lot number was not provided.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that during a procedure, the ring of the edwards cannula was found to be loose.There was no apparent damage on the packaging.There was no damage that anyone was aware of during preparation.The surgeon was able to complete the case with the cannula.The device was not replaced because the issue was not observed until after the device had been taken out of the patient.It was noted that the patient had aortic dissection, which may have been caused by the cannula slipping because the ring was not as secured as normal.

• Brand Name: EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSI
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7476446
• MDR Text Key: 107009208
• Report Number: 3008500478-2018-00065
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2018

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: EZC21A
• Device Catalogue Number: EZC21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 05/01/2018
• 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): Hospitalization; Required Intervention