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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 Problems Break (1069); Migration or Expulsion of Device (1395); Material Puncture/Hole (1504); Positioning Problem (3009)
Patient Problems Stroke/CVA (1770); Device Embedded In Tissue or Plaque (3165)
Event Date 08/21/2018
Event Type  Injury  
Manufacturer Narrative
The clamp device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. If the balloon bursts during a procedure, the heart would fill and warm, the operative site may be obscured and the procedure may need to convert to an open procedure. In this case, the surgeon popped the balloon with a suture needle. The root cause of this event was due to procedural/technique related factors. The subject device has not been returned for evaluation. Therefore, clinical observation cannot be confirmed due to no product return. The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. Edwards will continue to review and monitor all reported events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed. If new information becomes available, a supplemental report will be submitted.
 
Event Description
Edwards received information that the intraclude device balloon popped due to the surgeon's suture needle. During the case, both a proplege device and intraclude device were used. The proplege was placed and confirmed via fluoro in 18 minutes. The aorta was found to be 3. 1 cm. There was good arrest and good flows both antegrade and retrograde cardiopulmonary bypass (cpb). There were equal right/left arm pressures. On the last stitch at the left trigone, the suture needle popped the balloon of the intraclude device at 57 minutes of cross clamp time. The surgeon finished cosgrove band sewing, repaired the atriotomy, and the patient was weaned off bypass. The balloon slack was not all removed and after antegrade cardioplegia was administered, the intraclude balloon sat closer to the aortic valve than the ideal position. It was reported that the patient experienced stroke after the mini mvr procedure. The patient was noted to be doing better and improving.
 
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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 Key7881914
MDR Text Key120460083
Report Number3008500478-2018-00082
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberICF100
Device Catalogue 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 Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/17/2018 Patient Sequence Number: 1
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