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

Model Number	8300AB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Atrial fibrillation (af) is a common arrhythmia in patients undergoing cardiac surgery, including valve replacement.It is a common pre-existing condition, can be associated with the procedure, or can be a progression of the patient's disease at some point in the post-operative period.Although a well-recognized complication of heart surgery, it is typically not related to the device, but the procedure or underlying cardiac disease.It has been demonstrated that post-operative af tends to occur within 2 to 4 days after the procedure, with a peak incidence on postoperative day 2.70% of patients develop this arrhythmia before the end of post-operative day 4 and 94% before the end of post-operative day 6.Thus, events of atrial fibrillation occurring beyond the first postoperative week are much more likely to be due to the patient's underlying pathophysiology, rather than the implantation procedure.The root cause of this event cannot be determined with the available information.It was reported that the atrial fibrillation was almost resolved with medical intervention by pacing medication, and removing water.The surgeon commented that it was unknown if the event was device related.The subject device is not available for evaluation, as it remains implanted in the patient.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 or Problem Description
Edwards received information that atrial fibrillation was detected on the following day of the implantation surgery of a 19mm 8300ab aortic valve.This device was originally implanted to correct aortic stenosis and regurgitation secondary to mild calcification.Atrial fibrillation almost disappeared by pacing, medication, and removing water.The patient status was reported as 'recovered'.The surgeon commented that it was unknown whether this event was device related, and it was likely due to pressure load to the atrium.Of note, a mvr was also performed at the initial surgery.
Additional Manufacturer Narrative
H11.Corrected data - updated b5 and h6.
Event or Problem Description
Edwards received information that atrial fibrillation was detected on the following day of the implantation surgery of this 19mm valve.This device was originally implanted to correct aortic stenosis and regurgitation secondary to mild calcification.Atrial fibrillation was almost disappeared by cardioversion, medication, and removing water.The patient status was reported as recovered.The device was not returned for evaluation as it remained implanted.The surgeon commented that it was unknown whether this event was device related, and was likely due to pressure load to the atrium.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11247985
• Report Number: 2015691-2021-01047
• Device Sequence Number: 16835918
• Product Code: LWR
• UDI-Device Identifier: 00690103194470
• UDI-Public: 00690103194470
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: 8300AB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 48