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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 Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  Injury  
Manufacturer Narrative
Additional manufacturer narrative: if the catheter becomes occluded during use, it may require a catheter exchange or a change of operative strategy. The subject device was not returned for evaluation as it was discarded. The reported event cannot be confirmed with the available information. The root cause of this event cannot be conclusively determined. However, the event was likely due to procedural/technique related factors. Per the instructions for use (ifu), "care should be used when handling the devices. Damage may result from kinking or stretching the devices. Do not use the device if kinked. " edwards lifesciences will continue to monitor all reported events. No further actions are required at this time. If new information becomes available, a supplemental report will be submitted.
 
Event Description
Edwards received notification that this intraclude device model ifc100 was damaged during use. The procedure was a mitral valve repair with intraclude clamping. The intraclude was positioned in the ascending aorta with some difficulties in identifying the position of the tip of the device and additional placement maneuvers. The aortic clamping and cardioplegia delivery sequence was initiated. Aortic occlusion was visually confirmed on tee, but aortic root pressure did not drop after occlusion and cardioplegia did not completely stop the heart, showing high pressures and low flows. After a second attempt of cardioplegia delivery, the use of intraclude device was aborted, and the procedure continued with the use of an external clamp (chitwood clamp). As reported, the catheter was kinked/twisted while being placed in the aorta. Repair was successful and the mitral valve showed just a trivial regurgitation. The patient did not suffer any injury due to the aborted attempt to clamp the aorta with the intraclude device. Reportedly, the cannula and its packaging were inspected prior use following the instructions for use (ifu) and no issues were observed by the medical team neither on the device packaging nor in the device itself. The patient was noted as to have done very well and was discharged home. After discussion, the surgeons agreed that the root cause could have been a bad positioning and twist of the device.
 
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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
12050 lone peak parkway
draper UT 84020
Manufacturer Contact
amritha srinivasan
1 edwards way
mle-2
irvine, CA 92614
9492504062
MDR Report Key11672153
MDR Text Key253040561
Report Number2015691-2021-02464
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Device Lot Number63429969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2020
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: 04/15/2021 Patient Sequence Number: 1
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