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 Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation at this time.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 patient experienced an arrhythmia after the implantation of a valve model 8300ab27.As reported, an avb was developed.A permanent pacemaker was implanted.No concomitant myomectomy was performed at the time of device implant.This valve was explanted after an implant duration of four (4) days due to moderate-to-severe paravalvular leak at the level of the right coronary cusp.The explanted device was replaced with a valve model 11500a29.

Event Description

Edwards received notification that a patient experienced an arrhythmia after the implantation of a valve model 8300ab27.As reported, an avb was developed.The patient had no pre-operative history of arrhythmia and/or conduction disturbance.A permanent pacemaker was implanted on pod # 2.No concomitant myomectomy was performed at the time of device implant.The annulus was severely calcified.The debridement was not excessive but was complete.This valve was explanted after an implant duration of four (4) days due to moderate-to-severe paravalvular leak at the level of the right coronary cusp.The explanted device was replaced with a valve model 11500a29.

Manufacturer Narrative

The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.The device history record (dhr) review showed that this device passed all manufacturing and sterilization inspections prior to release for distribution.No non-conformances were identified that could be related with the reported event.Atrioventricular conduction disturbances after avr is associated with many patient-related and procedural-related factors.The mechanisms of the development of heart block after surgical avr is well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13016379
• MDR Text Key: 282327609
• Report Number: 2015691-2021-06846
• 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,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2022

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 Expiration Date: 02/02/2024
• 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: 11/21/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/04/2022
• Supplement Dates FDA Received: 01/10/2022; 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male