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

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.

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: 7881914
• MDR Text Key: 120460083
• Report Number: 3008500478-2018-00082
• 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,health
• 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 Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention