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Model Number ICF100
Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)
Patient Problem Occlusion (1984)
Event Date 05/29/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to edwards for evaluation. The clinical observation was unable to be confirmed. Per the instructions for use, the balloon should be positioned just above the sino-tubular junction and vigilance during the case is required. There are multiple warnings in the ifu regarding possible balloon migration during the case and recommendations on mitigations to prevent migration of the balloon. The vast majority of migrations are easily detected and corrected during mis cases. If significant balloon migration is not detected, it may result in damage of the aortic valve leaflets or myocardial ischemia from blockage of the coronary ostia. A definitive root cause cannot be determined at this time. No further corrective or preventative actions are required at this time. Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.
Event Description
Edwards received notification that a balloon migration occurred during use of an intraclude device, in a mitral and tricuspid valve surgery. As reported, the surgeon placed the intraclude off pump without any issues, the balloon was inflated and the aorta occluded. Then the surgeon opened the left atrium to place the atrial retractor to have a good exposure of the mitral valve. At this moment, the new atrial retractor was difficult to place (a lot of manipulation in the atrium). The intraclude moved towards to aortic valve as the slack was not completely removed. The heart started to beat again and blood was entering the operating field. The balloon was repositioned, the heart stopped and the surgeon continued with the placement of another atrial retractor. When the mitral valve was exposed, it was possible to see with the camera that there was too much volume in the balloon and that the balloon was too close to the aortic valve, also the root pressure was too high (30-40 mmhg). The systemic pressure of the left and right radial was around 40 mmhg. After a few minutes blood was entering the operating field and the activity in the heart restarted. This was due to proximal balloon migration (all the slack for the intraclude was not removed). Then, intraclude was repositioned followed by cardioplegia. This was still ok and the surgeon started to place some sutures in the annulus. After 10 minutes the balloon was again migrated towards the aortic valve and there was still slack in the catheter. It was decided to reposition the intraclude again. After that, it was noticed that the systemic pressure was very low. The anesthesiologist placed the cerebral monitor and immediately it was noted that the perfusion of the brain was too low. The surgeon declamped the aorta and continued on the fibrillating heart. When this was done all pressure went to normal range. The balloon was pulled back too much and was blocking all side braches in the aortic arch. The surgeon finished on the fibrillating heart. The patient was reported to be recovering, slowly waking up and reacting to everything.
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Manufacturer (Section D)
1 edwards way
irvine CA 92614
Manufacturer (Section G)
1 edwards way
irvine CA 92614
Manufacturer Contact
neil landry
1 edwards way
ms mle2
irvine, CA 92614
MDR Report Key6650540
MDR Text Key77864723
Report Number3008500478-2017-00038
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/19/2017 Patient Sequence Number: 1