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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2023

Event Type  malfunction  

Event Description

From staff: a 23mm inspiris resilia aortic valve was implanted on a patient.Everything looked fine at the time the valve was implanted.When coming off bypass, there appeared to be a leak coming from the valve.We went back on bypass to fix it.When the surgeon took the valve out, he thought it may have a little more of a gap between the leaflets than normal but wasn't sure if that was the cause of the leak or not.We opened another valve and went on to implant that with no issue.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 17904222
• MDR Text Key: 325275279
• Report Number: 17904222
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Male
• Patient Weight: 50 KG