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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); Burst Container or Vessel (1074); Migration or Expulsion of Device (1395); Decrease in Pressure (1490); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2019
Event Type  malfunction  
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.Per the instructions for use (ifu), the balloon should be positioned just above the sino-tubular junction and vigilance during the case is required.There are multiple warnings in the ifu regarding possible balloon migration during the case and recommendations on mitigation to prevent migration of the balloon.The root cause of this event cannot be determined with the available information.The device has not been returned for evaluation.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.Please reference mfr report #3008500478-2019-00114 for the first device used in this case.
 
Event Description
Edwards received notification that issues were experienced with intraclude devices during a cardiac minimal invasive robotic surgery.It was reported that the first device used had a balloon burst and the pressure decreased rapidly to 52 mmhg.The surgeon tried to inflate again but he came to the conclusion that the device was damaged.A second device was used (subject device), but in this case no occlusion was reached (pressure: 320 mmhg, occlusion: 80-90%).Initial volume of balloon was < 35 cc.No issue was noted during preparation of the device but after inflation, the balloon migrated.When the surgeons tried to reposition, the balloon was unseen on echo.There was no blood in the balloon lumen, no leaks noted and no balloon burst.The balloon was in the aorta.It was decided to use a mechanical clamp and finish the procedure via mini-thoracotomy.Decision to go in that way was taken after the heart started to beat and the balloon couldn¿t been seen on echo.The size of the aorta in this patient was noted to be close to 40 mm.The patient is reported to be fine and was discharged home.
 
Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
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Brand Name
INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
MDR Report Key8445067
MDR Text Key139818799
Report Number3008500478-2019-00115
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K163693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/16/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61369216
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2019
Initial Date FDA Received03/22/2019
Supplement Dates Manufacturer Received04/24/2019
07/23/2020
Supplement Dates FDA Received04/25/2019
12/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
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