MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 11500A23

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis (2100); Thrombus (2101); Stenosis (2263)

Event Date 10/17/2019

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.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, the valve was explanted on pod #15.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.A manufacturing non-conformance was not identified.A definitive root cause cannot be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.There was no indication or allegation of a device malfunction contributing to the event.The instructions for use (ifu) has been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events through the use of edwards quality systems.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further corrective or preventative actions are required at this time.

Event Description

Edwards received notification that a 23mm aortic valve was explanted due to a large thrombus leading to valve stenosis after 15 days of the implant.The patient was on anticoagulation therapy initially after the implant (depot heparin 4x5000 i.E.And the therapy with marcoumar was started) and prior to thrombosis diagnosis (depot heparin 4x5000 i.E).Blood products were administrated to the patient (3g fibrinogen, 1000 octaplex, 2 ampoules octostim).Another valve same size was used as replacement.The patient was reported to be fine.

Manufacturer Narrative

Edwards received additional information through follow-up.Supplemental report submitted to update concomitant medical products.The device will not be returned for evaluation as it was reported to have been discarded by the hospital.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9305498
• MDR Text Key: 167813820
• Report Number: 2015691-2019-04176
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2019

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: 03/04/2021
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 07/23/2020
• Supplement Dates FDA Received: 12/10/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention