MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ENDODIRECT ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EC65

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Date 03/24/2015

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: a dissection is a tear in the inner lining of the vasculature.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 tears that can occur that do not result in significant disturbances to blood flow and do not require intervention.Dissections typically occur as a result of the patient¿s diseased vasculature and technical errors resulting during the cannulation process.Of note, patient had a previous cardiac surgery in whom the ascending aorta adventitia was completely peeled off during the cannulation phase.This device is no longer in distribution.No further corrective or preventative actions are required at this time.

Event Description

Edwards learnt through review of article "aortic cannulation system for minimally invasive mitral valve surgery" - authors: cristina barbero,md et al ¿ of a study conducted between january 2006 and march 2014 in which a total of 624 mimvs procedures were performed.Introduction: port-access technology with an endoaortic clamp (ec) or transthoracic clamp has been widely adopted and confirmed as having excellent clinical outcomes.Nevertheless, concerns still remain about the risks of vascular and neurologic events potentially associated with the use of retrograde aortic perfusion and balloon manipulation, particularly in patients with aortoiliac atheromatous disease.Because of these concerns, a minimally invasive approach is denied to these high-risk patients relegating them to standard sternotomy.This situation prompted the development of a device for direct ascending aortic cannulation and clamping to extend minimally invasive mitral valve surgery (mimvs) even to patients initially ineligible.The endodirect (ed) cannula (edwards lifesciences, (b)(4)) allows antegrade arterial perfusion and insertion of an ec for aortic clamping, cardioplegia delivery, and aortic venting.Potentially, its use can avoid the risk of aortoiliac dissection and of retrograde embolism with neurologic injury related to retrograde aortic perfusion.It also provides a better stability for the ec and a lower risk of balloon migration.Objective: the aim of this study was to analyze retrospectively our results in the subgroup of patients undergoing mimvs in which ed technique was used.Results: (.) our experience underlines that it is definitely a useful and safe tool that allows us to extend mimvs also to this subgroup of high-risk patients.Within the context of this article the following event was identified: aortic injury that led to conversion to sternotomy.As reported, conversion to sternotomy was necessary to repair a tear in the ascending aorta in a patient with a previous cardiac surgery in whom the ascending aorta adventitia was completely peeled off during the cannulation phase.

Manufacturer Narrative

The ed24 device is inserted peripherally and does not directly contact or effect the ascending aorta.The reported tear in the ascending aorta is not directly related to the ed24 device.A manufacturing related issues was not identified.The complaint trend was assessed and found to be in control.A definitive root cause cannot be determined.

Event Description

After further investigation, it was reported that the patient¿s aorta was extremely fragile because of previous cardiac surgery.The mitral procedure was completed normally through the mini thoracotomy.The device functioned as intended and there was no device malfunction.At the end of the procedure ,during decannulation, an ascending aorta tear occurred which was impossible to control the bleeding.A conversion to sternotomy was performed.The aorta was replaced but the patient died in icu because of multiple organ failure (mof).

Manufacturer Narrative

Correction data: please remove the following statement in follow up #1 - "the ed24 device is inserted peripherally and does not directly contact or effect the ascending aorta.The reported tear in the ascending aorta is not directly related to the ed24 device." a device or manufacturing deficiency was not identified.

• Brand Name: ENDODIRECT ARTERIAL CANNULA
• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6395893
• MDR Text Key: 69616552
• Report Number: 3008500478-2017-00015
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K974736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2017

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: EC65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2017; 04/24/2017
• 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): Required Intervention