MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Code Available (3191); Multiple Organ Failure (3261)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Aortic tears, or a tear of the aortic wall, may occur as a complication of cardiac surgery involving a diseased aortic root.These aortic injuries are life threatening conditions that require urgent intervention with suture repair, pericardial patch repair or aortic root replacement.In this case, the aortic injury was reported to be possibly related to the patient's fragile tissue and some procedural related factors.The reported event cannot be confirmed; however, it appears that this event was due to patient and/or procedural related factors.There is no information indicating that there any malfunction of the edwards device.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification of an aborted attempt to implant a 23 mm intuity elite valve due to an aortic annulus injury noted after frame expansion.The device was chosen to implant due to presence of patient's scoliosis and poor visibility.The procedure was performed via mini-sternotomy with hockey sticky aortotomy.The patient had a narrow stj and calcification of the annulus and sub-annular structures.Anulus shape was irregular being the right coronary sinus deeper compare to the others.As reported, sizing was done with 21 mm and 23 mm sizers.Both fit good, although the 21 mm had a small space between the barrel and the annulus, so the 23 mm valve was selected.The subject device was parachuted into the annulus and balloon inflated.After frame expansion, they found a detachment of the subject device in the area of the noncoronary sinus.The valve was removed and a linear rupture of annulus at the noncoronary sinus noted.The surgeon thinks that the annular damage was not valve related but possibly due to the patient's fragile tissue and some procedural factors (the delivery system was not well connected).The annulus was repaired with a pericardial patch and a 21 mm magna ease valve was successfully implanted in replacement.After the patient has been weaned from cpb but being still on pump, a bleeding was noted at the left appendage due to the pericardial suction tube.To repair the small damage, it was necessary convert the mini-sternotomy to a median sternotomy with no adverse events for the patient.The surgeon said that this bleeding was not valve related.The patient was noted as to be hospitalized in the icu in stable conditions but died on pod #5 due to multiple organ dysfunction syndrome.As per the clinical observation, this death was not valve related.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7332895
• MDR Text Key: 102185591
• Report Number: 2015691-2018-00859
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2018

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 Expiration Date: 05/16/2021
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/12/2018
• Date Device Manufactured: 06/15/2017
• 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; Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 50