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

Model Number 8300ACD

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Regurgitation (2259); Stenosis (2263)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

This device is not sold or marketed in the united states; however, it is similar to the brand edwards intuity elite valve system , model# 8300ab, pma# p150036 the device was explanted > 0 days for unknown reasons.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.Re-operative valve surgery carries significant risk.The device was not returned for evaluation, as the follow-up for device return is ongoing.Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported via clinical trial that a 21mm aortic valve was explanted and replaced with another 21mm valve after an implant duration of 6 years, 7 months.As reported, the patient was admitted for mvr due to severe stenosis and mild regurgitation.During surgery it was difficult to see the mitral valve due to the study valve, therefore, the surgeon elected to remove the study valve and a non-edwards mitral valve was implanted.

Event Description

It was reported via clinical trial that a 21mm aortic valve was explanted and replaced with another 21mm valve after an implant duration of 6 years, 7 months due to leaflet thickening.As reported, the patient was admitted for mvr due to severe stenosis and mild regurgitation.During surgery it was difficult to see the mitral valve due to the study valve, therefore, the surgeon elected to remove the study valve and a non-edwards mitral valve was implanted.Per medical records the study valve had no stenosis or regurgitation.Upon replacement, excellent seating was seen without any loose areas.Post-op tee revealed excellent valve function with no significant perivavular leaks.The patient was transferred to icu in stable condition.On pod #6 the patient was anticipated to be discharged in next 24 hours.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated b5, d4, h3, h4, and h6 per new information received.There can be several root causes of leaflet thickening.There may be cases where the leaflet or leaflets are not functioning as intended leading to stenosis and/or regurgitation.Depending on the severity of the leaflet thickening, surgical/percutaneous intervention may be indicated or required after the initial surgery.H3: product evaluation customer report of leaflet thickening was confirmed.As received, leaflet 3 was in the open position.Open leaflet was able to be pushed back into closed position when probed.X-ray demonstrated wireform intact and frame expanded.Frame was pushed inward around leaflet 3, creating an ovular shape.All three leaflets were thickened and swollen near the commissures.Leaflets 1 and 2 had cuts approximately 7mm long near commissure 2.Edges of both cuts were straight and even and appeared to match up.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 1 at the outflow aspect.Valve frame had moderate host tissue overgrowth at the inflow aspect.No other visible inconsistencies were observed on the valve.Suture holes were visible near two of the three black stitch markings on the sewing ring; one suture hole near each.Wireform was exposed around leaflet 3 on the outflow aspect and on commissure 3.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11066316
• MDR Text Key: 223450611
• Report Number: 2015691-2020-15223
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2015
• Device Model Number: 8300ACD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 81