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Model Number ICF100
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Aortic Dissection (2491)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to edwards for evaluation as it remains implanted. Per the ifu, 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. In this case, an aortic dissection occurred in the arch of the aorta. Per medical opinion, this damage occurred due to the manipulation of the intraclude and the calcification existing in this area. A definitive root cause could not be determined; however, it is likely that patient related factors contributed to the event. As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis. If action is required based on the determined control limits, appropriate investigation will be performed. No corrective or preventative actions are required at this time.
Event Description
Edwards received notification that during use of an icf100 an aortic dissection and balloon displacement occurred. The case was a tricuspid replacement via mis approach. This was a redo case (aortic and mitral valve replacement in full sternotomy) for this male patient. As reported, the placement of the intraclude was done under tee guidance. All was ok and done as per ifu. At ecc start all pressures were normal. Surgeon started clamping the aorta: the inflation of balloon under tee guidance was done in a good way. Occlusion of the aorta and start cardioplegia was ok. At this moment the surgeon needed to remove the slack of the intraclude and position the balloon in the ascending aorta. This positioning was difficult and the surgeon had to do this 3 times under tee guidance, but after 2-3 minutes the proctors noticed that the left radial pressure was very low. The position of the balloon was checked on tee but it was no longer visible on tee. The cerebral oximetry was also declining, no change in left radial pressure. The proctor anesthetist used the echo to check the ascending aorta and arch to localize the intraclude, at the same time the hospital anesthetist checked pulsation in the left and right arm. No pulsation in left arm. The proctor found on tee the position of the intraclude in the arch aorta and he saw a dissection in the arch of the aorta in the area of the side branch of the left artery subclavian ( about 2 cm dissection). The proctors immediately decided to stop the use of the intraclude and pulled it into side arm of the endoreturn. The proctor anesthetist checked with the whole aorta to check for more dissections/lesions. The lesions was very small. The team decided to go forward with the procedure of the tricuspid. After this was done, again the whole aorta was checked. The dissection stayed in the same area, but went a few centimeters distal ( lesion of 5-6 cm). Type b dissection. Because of the antegrade flow of the heart and output they decided to leave it like this and do a ct scan later for follow up. After the procedure the patient was noted to be fine. Per clinical observation, the dissection was caused by the manipulation of the intraclude in the aorta. There was some calcification in the arch aorta. Probably due to the manipulation of the intraclude and the calcification, the intima was damaged and the dissection occurred.
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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
12050 lone peak parkway
draper, UT 84020
MDR Report Key7180269
MDR Text Key96904381
Report Number3008500478-2018-00054
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
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 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/13/2019
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number60972892
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 Received12/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/03/2017
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: 01/10/2018 Patient Sequence Number: 1