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

Model Number 8300AB21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Aortic Dissection (2491); Vascular Dissection (3160)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement and, less frequently, from mitral valve replacement.It is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute peri-operative right, left or bi-ventricular dysfunction and/or death.In this case, the scar tissue of the left main had separated and formed a dissection causing coronary ostial obstruction.Repair of the dissection and cabg x1 were performed.The 21mm aortic valve was explanted and replaced with another 21mm aortic valve of the same model successfully.The root cause was likely due to patient and/or procedural related factors.The subject device is not available for evaluation as patient authorization is required.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a 21mm 8300ab aortic pericardial valve was explanted at implant due to coronary ostial obstruction from dissection/fibrous scar tissue.The explanted valve was replaced with another 21mm 8300ab aortic valve.Per the medical records, the aortic root had to be enlarged as the patient had a small root to start with.The patient also had a subaortic membrane that was resected all around the left coronary cusp and the right coronary cusp subvalvular region.The lvot was enlarged by excising this membrane.The previous prosthetic aortic valve was excised and the annulus was debrided.The 21mm 8300ab valve was selected.Three sutures were placed at the nadir of the aortic valve annulus.These were secured to the intuity valve.The 21mm valve was then placed in the intra-annular position and the balloon was inflated for 10 seconds at 4-5 atm.The sutures were then tied.There was good apposition of the valve to the annulus.The patient had calcium shelves in the ascending aorta at the prior aortomy site.The aorta was repaired by excising the calcium area and the edges were brought together with mattress sutures.At the end of the repair, a good position and hemostasis of the aorta was obtained.The patient was weaned off bypass without any difficulty.At this point, it was found on echocardiogram that the patient had significant anterior wall dysfunction.The patient was placed on bypass again.The aorta was opened and the prosthetic aortic valve was removed.It was found that the scar tissue that was going to the left main had separated and formed a dissection of the left main.Sutures were placed to bring the left main to the aortic wall.At the end of the repair of the left main, there was excellent visualization of the ostium.Subsequently, cabg x1 was performed.Another 21mm 8300ab valve was implanted as replacement.The patient was weaned off bypass and protamine was administered.Hemostasis was satisfactory.The patient was transferred to the icu in stable condition.The patient was discharged home on pod #8 in stable condition.

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: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9458819
• MDR Text Key: 171609059
• Report Number: 2015691-2019-04608
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 8300AB21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR