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

Model Number 11500A19

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); No Information (3190)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device evaluation is anticipated but has not yet begun.A supplemental report will be submitted upon completion.

Event Description

It was reported that a 19mm aortic valve was explanted at implant due to coronary obstruction.A 21mm pericardial aortic valve was implanted successfully.The patient was reported to be stable.As reported, the procedure started as a rat approach.Post-implant tee images were unsatisfactory, and indicative of poor perfusion of the heart.The decision was made to reopen the aorta.Through rat incision which was very small, the surgeon could not see the right coronary ostium.Patient was converted to full sternotomy to allow further investigation.Surgeon still could not see right coronary ostium, and removed the 19mm valve.When surgeon was able to see coronaries, he stated they seemed "off centered".Surgeon re-implanted the 19mm valve with slight reorientation.Once the valve was re-seated, surgeon still could not visualize right coronary ostium.To correct the anatomy, and also due to the patient's bsa, a decision was made to perform a root enlargement and the 19mm valve was explanted.

Manufacturer Narrative

X-ray demonstrated wireform intact, however distorted near commissure 1.Suture holes were visible around the sewing ring.The wireform was exposed on commissure 1.Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement and, less frequently, from mitral valve replacement.It is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute peri-operative right, left or bi-ventricular dysfunction and/or death.In this case the rat incision was converted to full sternotomy due to obstruction.Based on the product evaluation, the customer report of "coronary obstruction" could not be confirmed through visual observations.The root cause of the event remains indeterminable but was likely due to procedural factors.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.There was no indication or allegation of a device malfunction contributing to the event.The ifu has been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 corrective or preventative actions are required.

Manufacturer Narrative

Corrected data: f10, h6.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: 7935094
• MDR Text Key: 122799351
• Report Number: 2015691-2018-04046
• 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,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 11500A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• 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
• Patient Age: 54 YR