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

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Dyspnea (1816)

Event Date 04/26/2022

Event Type  Injury  

Event Description

Edwards received notification that an elite valve model 8300ab25 implanted in the aortic position was explanted after an implant duration of seven (7) months and 23 days due to valve dehiscence leading to paravalvular leak (pvl).The issue was observed on 6-month-follow-up transesophageal echo.As reported, no calcification was present, the valve was working as expected and no deformity was noted.Reportedly, no pvl was present at implant.The patient was admitted for surgery with shortness of breath on mild exertion.Water test performed during re-intervention showed a small dehiscence of the valve at 3 oclock of the annulus.As reported, the valve frame was not expanded enough at that area, so the valve frame did not reach the tissue and no adherence was noted at the area where the leak was found.Surgeon stated there was nothing wrong with the valve, but this could be likely caused by an user error on implant.The explanted device was replaced with an inspiris resilia valve of the same size (25mm) with no complications.The patient left theatre in a stable condition and was discharged home on postoperative day 6.

Manufacturer Narrative

The subject device is not available for evaluation as it was discarded at site.Reportedly, customer was not willing to provide any further details about this event.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.No product, images, medical records were returned for evaluation.Based on the information available, the most likely cause of the pvl is the reported under expansion of the frame due to use error.

Event Description

Edwards received notification that an elite valve model 8300ab25 implanted in the aortic position was explanted after an implant duration of seven (7) months and 23 days due to paravalvular leak (pvl).The issue was observed on 6-month-follow-up transesophageal echo.As reported, no calcification was present, the valve was working as expected and no deformity was noted.Reportedly, no pvl was present at implant.The patient was admitted for surgery with shortness of breath on mild exertion.Water test performed during re-intervention showed a small gap of the valve at 3 oclock of the annulus.As reported, the valve frame was not expanded enough at that area, so the valve frame did not reach the tissue and no adherence was noted at the area where the leak was found.Surgeon stated there was nothing wrong with the valve, but this could be likely caused by an user error on implant.The explanted device was replaced with an inspiris resilia valve of the same size (25mm) with no complications.The patient left theatre in a stable condition and was discharged home on postoperative day 6.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14468637
• MDR Text Key: 292348387
• Report Number: 2015691-2022-05826
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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 Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG