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Model Number EC65
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 04/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention. In extreme cases, occlusion of blood flow to the coronary, carotid, or subclavian arteries can result in hemodynamic instability and/or death without surgical intervention. In this case, although there have been attempts to receive further information regarding the event, no additional details were provided. The device history record (dhr) review was not able to be completed as information regarding this device's lot number remains unknown. Trends are monitored on a monthly basis and if further information becomes available, a follow-up report will be submitted.
Event Description
Title - port access cardiac operations can be safely performed with either endoaortic balloon or chitwood clamp. Abstract - methods: all patients undergoing minimally invasive, port access, right thoracotomy operations from 1998 to 2012 at our institution were retrospectively analyzed. Patients undergoing aortic occlusion with the chitwood clamp (n
189) were compared with patients undergoing occlusion with the endoaortic balloon (n
875). Results: there was no statistical difference in the rate of dissection between patients undergoing aortic occlusion with an endoaortic balloon (1. 03%) and those receiving a chitwood clamp (1. 06%). Similarly, there was no difference in the rate of type a dissection between aortic occlusion strategies (endoaortic balloon
0. 57%, n
5, vs chitwood clamp
1. 06%, n
2, p
0. 28). No difference in the incidence of stroke was identified between the endoaortic balloon and the chitwood clamp (2. 2% vs 2. 1%, p
1. 0). Conclusions: minimally invasive cardiac operations using a peripheral cannulation strategy can be safely performed with minimal vascular adverse events incorporating either endoaortic balloon or chitwood clamp aortic occlusion. As experience with the endoaortic balloon is gained, the incidence of vascular adverse events can be reduced to nearly negligible rates. Summary - rate of intraoperative aortic dissection: total
1. 03%; type a
0. 57%; type a
0. 46%.
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Type of DeviceCLAMP
Manufacturer (Section D)
one edwards way
irvine CA 92614
Manufacturer (Section G)
one edwards way
irvine CA 92614
Manufacturer Contact
trushala nerurkar
1 edwards way
ms: lfs-33
irvine, CA 92614
MDR Report Key6541921
Report Number3008500478-2017-00032
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 04/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEC65
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 Received04/08/2017
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 Outcome(s) Required Intervention;