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

Model Number 11500A

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Left Ventricular Dysfunction (1947)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

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 patient required cabg x1 and iabp placement intraoperatively which resulted in marked improvement in the overall left ventricular function.There has been no indication or allegation of a product malfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.It has been determined that the root cause of this event was likely due to procedural related factors.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that a patient with prosthetic aortic valve endocarditis underwent redo-avr with a 11500a 21mm inspiris resilia valve.Debridement and closure of a perivalvular abscess cavity/fistula was performed.Mitral valve annuloplasty using a bovine pericardial patch was also performed.After weaning the patient from bypass, tee demonstrated evidence of left ventricular dysfunction.The septum, the anterior wall, and the lateral wall of the heart did not appear to be contracting.It was felt that there was likely some obstruction of the left main coronary artery.Therefore, the patient was placed back on bypass and cabg x1 was performed.An iabp was also placed.The patient was weaned from bypass again and tee showed marked improvement in the overall left ventricular function.The prosthetic aortic valve appeared to be functioning appropriately.There was no evidence of prosthetic valve regurgitation or perivalvular leak.The perivalvular abscess cavity was noted to be completely closed.The patient was taken to the icu in critical condition.The iabp was removed on pod #4.The patient tolerated the procedure well with no complications.

Manufacturer Narrative

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

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7782889
• MDR Text Key: 117136367
• Report Number: 2015691-2018-03362
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• 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
• Patient Age: 66 YR