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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 Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Death (1802); Diarrhea (1811); Ischemia (1942); Stenosis (2263); Aortic Dissection (2491)
Event Date 11/10/2017
Event Type  Death  
Manufacturer Narrative
It was learned that the subject device was used with an edwards endoreturn cannula.
 
Manufacturer Narrative
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. This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention. There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention. The root cause of this event cannot be conclusively determined with the available information. It is unknown if the subject device caused or contributed to the patient's death. Edwards will continue to review of all reported events and perform trend analysis on a monthly basis. If action is required, appropriate investigation will be performed.
 
Event Description
Edwards received notification that a patient expired 14 days after a surgery in which an intraclude device was used. The original surgery, a minimally invasive mitral valve repair using neochordae and annuloplasty ring, was uneventful. Extubation on the same day. On pod # 1 patient experienced abdominal pain with diarrhea. On pod # 2 patient was transferred from intensive care to intermediate care station. On pod # 6 stool samples were positive for clostridium difficile and antibiotic therapy was started. Symptoms improved, the patient was mobile, and discharge was planned. On pod # 11 end of diarrhea. On pod # 12 abdominal pain returned and ct-scan revealed an aortic dissection extending to the level of the mesenteric trunk to both iliac arteries, mesenteric arteries branching from false lumen, additional stenosis of superior mesenteric artery and signs of bowel ischemia. As reported, in the last ct-scan there was found some calcification of the abdominal aorta. The patient was taken for emergency abdominal surgery and complete irreversible ischemia of entire duodenum and colon was found. There was no therapeutic option and the patient expired.
 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
neil landry
12050 lone peak parkway
mle-2
draper, UT 84020
9492502289
MDR Report Key7102602
MDR Text Key106169780
Report Number3008500478-2017-00050
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/23/2019
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number60887220
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 Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2017
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: 12/10/2017 Patient Sequence Number: 1
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