MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number ICF100

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded by the hospital staff.The clinical observation was unable to be confirmed.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warnings: "hold the intraclude device shaft taut during balloon inflation.Slack in the intraclude device shaft may result in movement of the intraclude device towards the aortic valve.Do not discontinue bypass at this time as migration of the balloon may occur once bypass is reinitiated.If a reduction in pump flow is desired do not reduce arterial return more than 50% of full flow.Ensure that the balloon is above the sinotubular junction as inadequate coronary perfusion of cardioplegia could result if the sinotubular junction is blocked.The clamp-lock device or suture loop/box clamp must be locked and against the cannula/introducer hemostasis valve to prevent movement of the intraclude device towards the aortic valve.Use the locking devices on their intended areas only (extended strain relief for the clamp-lock and 9 fr catheter shaft for the suture loop/box clamp) use otherwise may result in migration of the intraclude device towards the aortic valve." there was no allegation of product malfunction.Manufacturing records were unable to be reviewed as not lot number was provided.Based on the information received, operational context most likely contributed this event.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.

Event Description

Edwards received information that the balloon ruptured while the annuloplasty ring was being sewed in.The suture needle punctured the balloon.The balloon migrated (unrecognized) toward the aortic valve after the cardioplegia was administered, and as the l trigone suture was placed, the needle punctured the valve.The device was replaced to finish the case.Unfortunately, the patient suffered iatrogenic aortic dissection (type b) as a new balloon was being inserted.No surgical intervention in the dissection has yet been required; however, he was converted from a robotic case to conventional sternotomy approach.It was reported that there was no fault in the balloon.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• 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; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6396370
• MDR Text Key: 69628673
• Report Number: 3008500478-2017-00016
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132175
• 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,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• 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): Other; Required Intervention