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

Model Number 8300AB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Block (4444)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation as it remains implanted in the patient.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.

Event Description

Edwards received notification that a 73 year old patient experienced a third-degree atrioventricular block (avb) after implantation of a 8300ab25 valve.As reported, this atrioventricular block occurred on the same date of procedure.Full sternotomy was performed.Calcium degree was severe and extensive especially in the right coronary sinus, therefore an aggressive debridement was performed.Peak gradients of 150 mmhg were noticed.The final position of the valve was the one intended, three extra sutures were placed in the right coronary sinus since it was a concern of possible leak there.Cross-clamp time was 137 min, cec time was 177min.After the procedure there was no pvl, and the mean post-operative gradient was 19 mmhg.A permanent pacemaker was implanted three days after valve implantation.

Manufacturer Narrative

Added information to section h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).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.Heart block, also known as av block, is when the electrical signal that controls the heartbeat is partially or completely blocked.This makes the heart beat slowly or skip beats hinders the ability for the heart to pump blood effectively.Symptoms include dizziness, syncope, tiredness and shortness of breath.Pacemaker implantation is a common treatment.The reason for post-operative av block after surgical valve replacement is related to injury to the cardiac conduction system during surgical excision of the adjacent diseased valve and annular tissue.In addition, heart block can result from mechanical pressure from the device sewing ring against the conductive system.The close anatomical relationship between the valvular complex and the branching atrioventricular bundle explains the possible development of conduction abnormalities following prosthetic valve procedures.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• 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 ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18807956
• MDR Text Key: 336566201
• Report Number: 2015691-2024-01451
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male