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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES INTRACLUSE INTRA-AORTIC OCCLUSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number ICF100
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 11/01/2011
Event Type  Injury  
Manufacturer Narrative
F10. Patient code: 3191
=
change in operative strategy and device code 3191
=
loss of balloon pressure. H10. Additional manufacturer narrative: the device was not return to edwards for evaluation. The clinical observation was unable to be confirmed. Manufacturing records were not reviewed as no lot number was provided. A definitive root cause cannot be determined at this time. No further corrective or preventative actions are required at this time. Trends will continue to be monitored through the use of edwards quality systems.
 
Event Description
Edwards learned through review of article "comparing the endo-aortic balloon and the external aortic clamp in minimally invasive mitral valve surgery", author mohamed bentala and al of a comparative study aimed to assess the differences in perioperative outcomes and complications between the endo-aortic balloon (eab) (endoclamp or its successor, intraclude) and the external aortic clamp (eac) (non-ew device) during primary elective minimally invasive mitral valve surgery. Two-hundred and twenty-one patients were included in this study. Patients operated on between november 2010 and november 2011 (n
=
54) were clamped with eac. From november 2011 until march 2014, patients were aortic-clamped with the use of the eab. Within the context of this article 1 conversion from eab to eac for loss of balloon pressure.
 
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Brand NameINTRACLUSE INTRA-AORTIC OCCLUSION DEVICE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irivne CA 92614
Manufacturer Contact
trushala nerurkar
one edwards way
ms lfs33
irivne, CA 92614
9492501377
MDR Report Key6538827
MDR Text Key74231126
Report Number3008500478-2017-00030
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K132175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
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 Received04/07/2017
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 Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
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