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 09/13/2016

Event Type  Injury  

Manufacturer Narrative

Product evaluation was not performed as the device was discarded by the hospital staff.The clinical observation was unable to be confirmed.Manufacturing records were unable to be reviewed as no lot number was provided.A manufacturing deficiency or product deficiency was not identified.Based on the information received, operational context and patient's anatomical condition contributed to this event.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.Injuries to the aorta or artery through which it is inserted are listed as a potential complication in the product ifu.The ifu provides the following warnings: "ensure the guidewire precedes the occlusion device to prevent damage to aortic valve or artery.Failure to advance over a guidewire may result in dissection or perforation of the artery.If a dissection or perforation is detected, do not initiate or continue bypass as it may propagate dissection.Do not advance the occlusion device if resistance is felt.Inability to easily advance the occlusion device may indicate vascular disease or injury." the training material instructs physicians to perform pre-operative tests such as a ct angiography prior to the case to detect vascular complications which are undetected by cardiac catheterization.In case where the presence of certain anatomical conditions exist, femoral arterial perfusion may be contraindicated.The fmea adequately addresses potential causes of failure and the associated hazards.The complaint trend was assessed and was found to be in control.No 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 notified of an aortic dissection that occurred after difficulty placing an intra-aortic occlusion device.The surgeon cannulated the right femoral artery with a cannula with no problem.He then attempted to insert the occlusion device, which would not pass through the patient's ascending aorta.He opted to use an another cannula in the left femoral artery and left the original cannula in the right femoral artery.Echo had been used during guidewire placement, but fluoro was brought in only after encountering difficulty placing the occlusion device.The imaging showed the patient had a very tortuous femoral artery.There were no other anatomical variances.After closing the left atrium following the robotic mvr, the patient developed an aortic dissection.As a result of the dissection, the patient required aortic valve replacement along with replacement of the aortic root and ascending aorta with concomitant right coronary artery bypass grafting.A ct angiogram was not performed prior to the procedure as the patient was transferred form an outside facility.The surgeon believed that there was damage to the intima of the femoral artery when trying to insert the occlusion device.This likely resulted in a tear in the femoral, which extended to the aorta.The patient left the or in stable condition.Subsequently, patient suffered from a parietal lobe stroke.On postoperative day one (1), did not have doppler pulse in the left leg.A ct angiogram showed the patient had dissections of all of his major blood vessels.He became acidotic and expired in the afternoon of post-operative day one due to the dissection caused ischemia to multiple organ systems.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6015333
• MDR Text Key: 56912012
• Report Number: 3008500478-2016-00037
• 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
• Report Date: 09/13/2016

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?: No
• 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: 09/13/2016
• Initial Date FDA Received: 10/10/2016
• 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): Death
• Patient Age: 73 YR
• Patient Weight: 80