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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Dissection (2491)
Event Date 08/29/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.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.Injuries to the aorta are listed as a potential complication in the product ifu.The ifu provides the following warnings and instructions: ¿ensure the guidewire precedes the intraclude device to prevent damage to aortic valve or artery.Failure to advance over a guidewire may result in dissection or perforation of the artery.If a dissection or perforation is detected, do not initiate or continue bypass as it may propagate dissection.Do not advance the intraclude device if resistance is felt.Inability to easily advance the intraclude device may indicate vascular disease or injury.While keeping the guidewire in place, bring the intraclude device up to the descending aorta and verify that it is intraluminal through tee and/or fluoroscopy visualization.While keeping the guidewire in place, bring the intraclude device up to the ascending aorta using tee and/or fluoroscopy visualization.The balloon should be located just above the sinotubular junction.Ensure the balloon is correctly placed in the aorta to prevent damage to the aortic valve or inadequate cerebral perfusion.Avoid excessive shaft retraction, as vascular injury and/or inadequate cerebral perfusion could result if the brachiocephalic junction is blocked.¿ a manufacturing deficiency was not identified.Based on the information received, operational context contributed to this event.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 was informed regarding an aortic dissection during the use of an intra-aortic occlusion device and arterial cannula.The guidewire and device was inserted by standard femoral cannulation for mitral and tricuspid repair in a patient with a previous aortic valve replacement (aorta size 38mm).The intra-aortic occlusion device was advance over the guidewire and positioned under tee control.When the device was in the correct position, the cpb was initiated, suddenly no signal on the monitor for the right arterial radials.Left side was noted to be okay.Under tee control a type a dissection was noted and the procedure was converted to a full sternotomy.The descended aorta and aortic arch was replaced.The patient's aorta was normal without any evident of disease.No deficiencies were noted before use.The valves were not replaced.After the completion of the procedure, the patient was transferred to icu.Two days post-operatively, patient expired due to massive diffuse ischemia.
 
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Brand Name
INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
12050 lone peak parkway
draper UT 84020
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
neil landry
1 edwards way
ms t&d2
irvine, CA 92614
9492502289
MDR Report Key5998167
MDR Text Key56411803
Report Number3008500478-2016-00035
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 09/09/2016
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 Expiration Date03/01/2018
Device Model NumberICF100
Device Lot Number60305630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/09/2016
Initial Date FDA Received10/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight53
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