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

This is one of three manufacturer reports (33660, 33662 and 33663) being submitted for this article.H10: additional manufacturer narrative: the date of event is unknown, therefore the first date (1 may 2014) based on the date range provided (may 2014 and may 2017) is being used as the date of event.Article citation: mogilansky, c.; massoudy, p.; czesla, m.; balan, r.Conduction disorders after surgical aortic valve replacement using a rapid deployment aortic valve prosthesis: medium-term follow-up.J.Clin.Med.2023, 12, 2083.Https://doi.Org/10.3390/jcm12052083 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

Through review of medical article " conduction disorders after surgical aortic valve replacement using a rapid deployment aortic valve prosthesis: medium-term follow-up", the following event was identified as pertaining to an edwards device: 15 patients with a valve model 8300ab implanted in the aortic position had a permanent pacemaker implantation due to av block iii after an unknown implant duration during the postoperative period.

Manufacturer Narrative

Updated section h6 (investigation findings) and h6 (investigations conclusions).The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The reason for post-operative av block after surgical avr is related to injury to the cardiac conduction system during surgical excision of the adjacent diseased valve and annular tissue.The close anatomical relationship between the valvular complex and the branching atrioventricular bundle explains the possible development of conduction abnormalities following prosthetic valve procedures.Atrioventricular conduction disturbances after tavr and avr are associated with many patient-related and procedural-related factors.The mechanisms of the development of heart block after tavr and surgical avr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop post-operative heart block, potentially requiring a permanent pacemaker.As a result, in depth investigation of these events is not warranted.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: 17376726
• MDR Text Key: 319660139
• Report Number: 2015691-2023-14781
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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