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

Model Number 8300AB

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remained implanted.The device history record (dhr) could not be reviewed as a serial number was not provided.Aortic tears, or a tear of the aortic wall, may occur as a complication of cardiac surgery involving a diseased aortic root.Additional causes of aortic tears or a tear of the aortic wall may be related to the use or misuse of the edwards intuity valve.These aortic injuries are life threatening conditions that require urgent intervention with suture repair, pericardial patch repair or aortic root replacement.The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.No corrective or preventative actions apply to this case.A definitive root cause could not be determined.As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based on the determined control limits, appropriate investigation will be performed.No corrective or preventative actions are required at this time.

Event Description

Edwards received notification that a bleeding into the left ventricle muscle near the aortic root was observed soon after the implantation of a 23 mm valve.The surgeon added two pledged stitches on the muscle and then put glue and surgicel to stop the bleeding.The device remained implanted.

Event Description

Edwards received notification that a bleeding into the left ventricle muscle near the aortic root was observed soon after the implantation of a 23mm valve.The surgeon added two pledged stitches on the muscle and then put glue and surgicel to stop the bleeding.Three sizers were tested 21mm (too loose), 23mm (comfort) and 25mm (too tight) so 23mm size was choose.The seating was easy and in very good place.As per medical opinion, the damage was not cause by the valve.The device remained implanted.The patient outcome was good and recovering well.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, REPLACEMENT
• 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; lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7139259
• MDR Text Key: 95585045
• Report Number: 2015691-2017-04460
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P150036
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• 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: 74 YR