MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

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

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation at hospital discarded it.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve/ring.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.The cause of the event was likely due to patient factors/condition.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.

Event Description

Edwards received information that a 21mm pericardial aortic valve, implanted approximately ten (10) months, was explanted due to thrombus attached to the leaflets.The device was originally implanted for aortic valve replacement.After implant, the patient had aortic dissection (stanford type a) and emergency surgery was performed.During the surgery, thrombus was attached to the leaflets and sinus of valsalva.The device was explanted and replaced with a 21mm pericardial aortic valve with no adverse patient events reported.The patient status was reported as under treatment.The device was not returned for evaluation as it was discarded by the hospital.There was no allegation of device malfunction.The surgeon commented that the patient did not take warfarin on a regular basis and it led to thrombus formation.

Manufacturer Narrative

H10.Additional manufacturer narrative: the cause of the event cannot be determined.Added h6 conclusion code, corrected data: corrected h6 conclusion code (remove cause due to patient condition).

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11516706
• MDR Text Key: 240696020
• Report Number: 2015691-2021-01935
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention