MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC INSPIRIS RESILIA AORTIC VALVE 29 MM BOVINE PERICARDIAL VALVE, EDWARDS LIFESCIENC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Microbial Contamination of Device (2303)

Patient Problems Retinal Injury (2048); Sepsis (2067); Fungal Infection (2419); Embolism/Embolus (4438)

Event Date 10/05/2022

Event Type  Death  

Event Description

Patient had an aortic valve replacement with an edwards inspiris bovine pericardial valve on (b)(6) 2022.He subsequently developed visual changes c/w septic retinal emboli.Tee revealed an aortic valve vegetation.Went to surgery for aortic valve replacement on (b)(6) 2022 and the valve cultures grew scedosporium.Valve pathology c/w same pathogen.Fungal blood cultures also grew scedosporium.This patient was not immune suppressed.Our lab has not identified any other scedosporium isolates in the past year from any other sources.Concern for possible fungal contamination of bovine prosthetic valve.Fda safety report id# (b)(4).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE 29 MM BOVINE PERICARDIAL VALVE, EDWARDS LIFESCIENC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 15673322
• MDR Text Key: 302477399
• Report Number: MW5112837
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White