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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 12/15/2016
Event Type  Death  
Manufacturer Narrative
Through investigation, this adverse event was non-device related and was most likely operational context and patient's clinical condition. No further action is required as there was no product deficiency. Trends will continue to be monitored through the use of edwards quality systems.
 
Event Description
Edwards was notified that during a procedure when inserting the guidewire, the surgeon realized that the wire followed a wrong lumen, causing aortic dissection. The operatory approach was immediately converted into full sternotomy, but due to a series of concomitant problems, the patient unfortunately died. As per surgeon's opinion, the issue was not related with a malfunction of the device.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Type of DeviceCLAMP, 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
trushala nerurkar
1 edwards way
irvine, CA 92614
9492501377
MDR Report Key6251738
MDR Text Key64881818
Report Number3008500478-2017-00002
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K132175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
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 Received12/20/2016
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: 01/13/2017 Patient Sequence Number: 1
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