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

Model Number ICF100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Injuries to the aorta are listed as a potential complication in the product ifu.The ifu provides the following warnings and instructions: ¿ensure the guidewire precedes the intraclude device to prevent damage to aortic valve or artery.Failure to advance over a guidewire may result in dissection or perforation of the artery.If a dissection or perforation is detected, do not initiate or continue bypass as it may propagate dissection.Do not advance the intraclude device if resistance is felt.Inability to easily advance the intraclude device may indicate vascular disease or injury.While keeping the guidewire in place, bring the intraclude device up to the descending aorta and verify that it is intraluminal through tee and/or fluoroscopy visualization.While keeping the guidewire in place, bring the intraclude device up to the ascending aorta using tee and/or fluoroscopy visualization.The balloon should be located just above the sinotubular junction.Ensure the balloon is correctly placed in the aorta to prevent damage to the aortic valve or inadequate cerebral perfusion.Avoid excessive shaft retraction, as vascular injury and/or inadequate cerebral perfusion could result if the brachiocephalic junction is blocked.¿ a manufacturing deficiency was not identified.Based on the information received, operational context contributed to this event.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

Edwards was informed regarding an aortic dissection during the use of an intra-aortic occlusion device and arterial cannula.The guidewire and device was inserted by standard femoral cannulation for mitral and tricuspid repair in a patient with a previous aortic valve replacement (aorta size 38mm).The intra-aortic occlusion device was advance over the guidewire and positioned under tee control.When the device was in the correct position, the cpb was initiated, suddenly no signal on the monitor for the right arterial radials.Left side was noted to be okay.Under tee control a type a dissection was noted and the procedure was converted to a full sternotomy.The descended aorta and aortic arch was replaced.The patient's aorta was normal without any evident of disease.No deficiencies were noted before use.The valves were not replaced.After the completion of the procedure, the patient was transferred to icu.Two days post-operatively, patient expired due to massive diffuse ischemia.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms t&d2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5998167
• MDR Text Key: 56411803
• Report Number: 3008500478-2016-00035
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: ICF100
• Device Lot Number: 60305630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 53