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

Model Number 8300AB

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Additional narratives: regurgitation/insufficiency of prosthetic valves may be caused by many different root causes.Surgical/percutaneous intervention may be indicated or required.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that a patient with a 25mm aortic valve underwent a bav procedure after an implant duration of 2 months due to severe regurgitation.A 26mm true balloon was used to dilate the surgical valve.No perivalvular leak was noted post dilation with trivial central regurgitation.

Event Description

It was reported that a patient with a 8300ab 25mm aortic valve underwent a bav procedure after an implant duration of 2 months due to severe pvl.The patient presented with nyha class iii, and symptoms of exertional fatigue and shortness of breath, lower extremity edema consistent with chronic diastolic congestive heart failure.A 26mm true balloon was used to dilate the surgical valve.No perivalvular leak was noted post dilation with trivial central regurgitation.

Manufacturer Narrative

Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus or improper seating.The most common reason for pvl is inadequate debridement of a calcified annulus and is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure.

Manufacturer Narrative

H10: additional narratives: updated d4, h4, and h6 per new information received.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.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: 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: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 15988478
• MDR Text Key: 305534266
• Report Number: 2015691-2022-10028
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194500
• UDI-Public: (01)00690103194500(17)250616
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

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
• Device Catalogue Number: 8300AB25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 02/02/2023
• Supplement Dates FDA Received: 01/09/2023; 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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; Life Threatening; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male