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

Model Number 8300AB25

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); No Code Available (3191)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).As reported, the issue occurred after implantation of the prosthetic valve.While removing the 25mm valve, an annular rupture occurred as a result of cor-knot suture removal.It was noted that the patient did not have friable tissue.The surgeon indicated that the 25mm was oversized.The explanted device was successfully replaced with a 25mm non-edwards valve.There has been no allegation of device malfunction or deficiency.It has been determined that this event was most likely due to procedural related factors.The subject device has not been returned for evaluation.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 25mm pericardial aortic valve was explanted at implant due to oversizing and improper seating resulting in aortic insufficiency (ai) and paravalvular leak (pvl).Access was gained with an upper hemi-sternotomy and hockey stick aortotomy.The annulus was sized with 21mm, 23mm, and 25mm sizers.While removing the 25mm valve, an annular rupture occurred as a result of cor-knot suture removal.It was noted that the patient did not have friable tissue.The annulus was resized with 25mm and 27mm sizers.The explanted valve was replaced with a 25mm non-edwards surgical valve.

Manufacturer Narrative

Evaluation summary: customer complaint of sizing, seating issues, aortic insufficiency, and paravalvular leak could not be confirmed through visual observations.X-ray demonstrated wireform intact and frame expanded.Mechanical damage was observed on the outflow aspect of all three leaflets and appeared to be serrated.Suture holes were visible near all three black stitch markings on the sewing ring; one suture hole near each.Sewing cloth was cut near the black stitch marking at leaflet 2.

Event Description

Per the operative report, the annulus was measured to a 25mm valve.The valve was seated on the annulus and each suture was snared down.The valve was deployed.The aorta was closed.The heart and aorta was de-aired and the clamp was released.Immediately, the heart got distended and was fibrillating.On echo, there was a large paravalvular leak.The surgeon completed mediastinotomy to do a regular sternotomy.The aorta was re-clamped.Diastolic cardiac arrest was provided and then it was observed in the noncoronary and partial left coronary cusp, the valve was not seated well.The 25mm aortic valve was explanted.The annulus was resized to a 23mm non-edwards valve and it fit perfectly.There was no valvular leak.The valve was functioning well.The tee showed the perfect valve function without paravalvular leak.The patient was weaned off from bypass.The patient tolerated the procedure well and was transferred to the icu in stable condition.

• 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: 7596213
• MDR Text Key: 110894498
• Report Number: 2015691-2018-02263
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• 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