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 07/04/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards evaluation.The reported clinical observation was unable to be confirmed.Manufacturing records were unable to be reviewed as no lot number was provided.Base on the information provided, a definitive root cause could not be determined.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.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 received information regarding a patient that presented with an aorta dissection three days post mitral valve surgery.The mitral valve surgery was a minimally invasive procedure and an intra-aortic occlusion device was used.There was no report of issues during the mitral valve surgery, and the surgeon confirmed that the intra-aortic occlusion device worked as intended throughout the procedure.The ascending aorta was 4.2 cm.The patient underwent surgery to correct the aortic dissection.The patient was discharged one week later.As per medical opinion, the potential cause could have been the use of the intra-aortic occlusion device, the guidewire or it could developed spontaneously as aortic dissection is a potential complication for all cardiac surgery.

• 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; irivne CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5836740
• MDR Text Key: 50848954
• Report Number: 3008500478-2016-00024
• 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
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/07/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/01/2016
• 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: 68 YR