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

Model Number ICF100

Device Problems Inflation Problem (1310); Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the explanted valve has been returned for evaluation.Device evaluation anticipated, but not yet begun.A supplemental report will be submitted once the evaluation has been completed.

Event Description

Edwards received notification that during the use of an intraclude device a balloon rupture occurred.The case involved a patient who was operated for a mitral prolapse p2.Pre-operative tee showed a normal aorta with no calcification.The customer was trained and experienced with this device.The intraclude was prepared as per the instructions for use (ifu).No abnormalities were found during prepping of the balloon.The customer always work with a final pressure of 300 mmhg.During the procedure, the balloon pressure went down from 300 to 280 and the balloon had to be filled up to 300 by adding 20 cc several times (they did not know the number of times).The rupture occurred almost at the end of the procedure.There was a quick progressive loss of balloon pressure.Due to that it was at the end of the procedure, there was no need to change the operative strategy.The atrium was closed and the peacemaker wires placed (normal placement, not near to the balloon).There was no adverse for the patient who was doing well after the procedure.

Manufacturer Narrative

Evaluation summary: customer complaint of "balloon rupture" was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the balloon was observed to be ruptured.Edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.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 root cause has been determined to be related to a supplier manufacturing defect.The supplier has indicated that the issue is currently being investigated.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 the use of an intraclude device a balloon rupture occurred.The case involved a patient who was operated for a mitral prolapse p2.Pre-operative tee showed a normal aorta with no calcification.The customer was trained and experienced with this device.The intraclude was prepared as per the instructions for use (ifu).No abnormalities were found during prepping of the balloon.The customer always work with a final pressure of 300 mmhg.During the procedure, the balloon pressure went down from 300 to 280 and the balloon had to be filled up to 300 by adding 20 cc several times (final volume added around 60 ml).The rupture occurred almost at the end of the procedure.There was a sudden, very quick loss of balloon pressure.Due to that it was at the end of the procedure, there was no need to change the operative strategy.The atrium was closed and the peacemaker wires placed (normal placement, not near to the balloon).There was no adverse for the patient who was doing well after the procedure.

Manufacturer Narrative

Reference capa-20-00141.

• 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 Key: 8514773
• MDR Text Key: 142338637
• Report Number: 3008500478-2019-00121
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2019

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 Date: 11/26/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 06/17/2019; 07/23/2020
• Supplement Dates FDA Received: 05/08/2019; 06/18/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70