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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER Back to Search Results
Model Number ICF100
Event Date 06/01/2018
Event Type  Death  
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, after the balloon rupture, the surgery was finished in cold ventricular fibrillation. As per surgeon´s opinion, the death was probably not related with the device as per patient pre-operative conditions. The device was not returned for evaluation at this time. The root cause of the rupture remains indeterminable. If new information is received, a supplemental report will be submitted. The device history record (dhr) was not able to be reviewed as the device lot number was not provided. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

 
Event Description

Edwards received notification that during a mitral valve replacement (mvr) surgery, the balloon of an intra-aortic occlusion catheter ruptured during use. After balloon rupture, the surgery was finished in cold ventricular fibrillation (bailout strategy). After extubation the patient was transfer to icu where the patient had to be re-intubated due to being adynamic, weak and ran into respiratory insufficiency. Brain damage showed no pathological finding. Patient had nosocomial infection that deteriorated developing renal failure. Patient passed away on pod+5 from multiple organ failure. This high-risk female patient had acute infective endocarditis and was in very critical condition on admission. As per surgeon´s opinion, the death was probably not related with the device as per patient pre-operative conditions. In mvr surgeries, consequences of balloon rupture imply de-airing challenge because low pressure with backflow of cardioplegia into lv through av occur. The surgeon and medical team are very experienced with the device (around 400 cases so far). Normal procedure includes: initial balloon volumen was 20ml, then adding additional volumen until device does not move. Target balloon pressure was 350 mmhg. At the time of this case, patient´s ct scan was not done regularly in all patients (contraindication in case of plaques, calcification) and they were not strict with limiting patients to 40mm aorta size (as per ifu) so it could be a bit bigger.

 
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Brand NameINTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
Type of DeviceINTRA-AORTIC OCCLUSION CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
mle-2
irvine , CA 92614
9492504062
MDR Report Key8620026
Report Number3008500478-2019-00133
Device Sequence Number1
Product CodeDXC
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 04/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received06/21/2019
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: 05/17/2019 Patient Sequence Number: 1
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