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

Model Number ICF100

Device Problems Break (1069); Burst Container or Vessel (1074); Migration or Expulsion of Device (1395); Decrease in Pressure (1490); Migration (4003)

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

Event Date 02/27/2019

Event Type  malfunction  

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.Per the instructions for use (ifu), the balloon should be positioned just above the sino-tubular junction and vigilance during the case is required.There are multiple warnings in the ifu regarding possible balloon migration during the case and recommendations on mitigation to prevent migration of the balloon.The root cause of this event cannot be determined with the available information.The device has not been returned for evaluation.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.Please reference mfr report #3008500478-2019-00114 for the first device used in this case.

Event Description

Edwards received notification that issues were experienced with intraclude devices during a cardiac minimal invasive robotic surgery.It was reported that the first device used had a balloon burst and the pressure decreased rapidly to 52 mmhg.The surgeon tried to inflate again but he came to the conclusion that the device was damaged.A second device was used (subject device), but in this case no occlusion was reached (pressure: 320 mmhg, occlusion: 80-90%).Initial volume of balloon was < 35 cc.No issue was noted during preparation of the device but after inflation, the balloon migrated.When the surgeons tried to reposition, the balloon was unseen on echo.There was no blood in the balloon lumen, no leaks noted and no balloon burst.The balloon was in the aorta.It was decided to use a mechanical clamp and finish the procedure via mini-thoracotomy.Decision to go in that way was taken after the heart started to beat and the balloon couldn¿t been seen on echo.The size of the aorta in this patient was noted to be close to 40 mm.The patient is reported to be fine and was discharged home.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

Manufacturer Narrative

Corrected data: f10, h6.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: 8445067
• MDR Text Key: 139818799
• Report Number: 3008500478-2019-00115
• 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
• Report Date: 02/27/2019

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: 05/16/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61369216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/24/2019; 07/23/2020
• Supplement Dates FDA Received: 04/25/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR