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

Model Number ICF100

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395)

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

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the customer report of a small hole in the balloon was confirmed.The device evaluation revealed that the intra-aortic occlusion device balloon would not maintain inflation due to a pink hole leak in the balloon and interlumen leakage between the inflation lumen and the aortic root infusion lumen.The interlumen leakage was found approximately 2.5 cm distal from the hub.Additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

Edwards received information that during the use of an intra-aortic occlusion device, the balloon appeared elongated and migrated during the case after 76 minutes of use.The planned procedure was a robotic mitral valve repair/replacement.Tee and fluoroscopy were used for placement.The decision was made to convert to open sternotomy due to an oddly shaped atrium and inability to visualize the entire mitral valve.With the device migration issue, the surgeon also felt it was better to use a traditional crossclamp to avoid any further balloon migration issues.It was reported that the aorta had what appeared to be a buckle in it.This was visualized during placement.The customer advised that the buckle was not an area of calcification.The aorta was soft, and was very long from the ascending aorta to the aortic arch.The surgeon was unsure if these anatomical variances contributed to the balloon migration.Upon removal of the device, the balloon was inspected, and blood staining of the fluid within the balloon was found.The balloon was re-inflated outside the patient, and a spray of fluid was noted coming from the tip of the balloon.A small hole was found.No complications related to this event were reported.The patient was awake, extubated and transferring out of the icu to step down on post-operative day #1.The surgeon was a very experienced user of the device.

Manufacturer Narrative

The device was sent to the supplier for further evaluation.The preliminary supplier evaluation was received and the final engineering and supplier report is pending.At this time, the cause of the balloon leakage is indeterminable.

Manufacturer Narrative

Evaluation result - balloon pinhole leak, interlumen leak.Evaluation conclusion - not a confirmed manufacturing deficiency, unknown root cause.A manufacturing related defect was not confirmed.The root cause of the balloon pinhole leakage could not be definitively determined.The interlumen leakage likely occurred during removal of the device.Manufacturing records were unable to be reviewed due to no lot number being provided by the customer.The instructions for use (ifu) were reviewed, and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• 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; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; m/s mle 8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5648823
• MDR Text Key: 44989633
• Report Number: 3008500478-2016-00016
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 04/15/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/29/2016; 07/12/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113