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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Appropriate Term/Code Not Available (3191)

Patient Problems Thrombosis (2100); Patient Problem/Medical Problem (2688)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

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.In this case, thrombosis was observed approximately one (1) year after implant of the surgical valve.The patient is being observed and treated medically.The root cause of this event cannot be determined with the available information.However, there is no information suggesting there was any device malfunction and/or deficiency.This event was likely due to patient and/or procedural related factors.The subject device could not be returned as it remains implanted within the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.In this case, a definitive root cause for early calcification and pannus could not be conclusively determined.However, there are no indications of a manufacturing defect.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 "leaflet thrombosis " or "sub valvular thrombosis¿ was observed on a (b)(6) years old female patient with an inspiris resilia valve model 11500a after implant duration of aprox one year.As reported, at the time of implant gradients were good(8-9).One year after patient returned recently feeling unwell.Echo showed high gradients of 3 and also showed thrombus on 1 leaflet.Patient is now on warfarin whilst they monitor things and is potentially a re-do.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9741654
• MDR Text Key: 190131350
• Report Number: 2015691-2020-10641
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention