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

Model Number 11500A

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

The 23mm inspisis valve was attested to the field and found to be in good working order.The valve was implanted into the chest however it was noted that once the sutures were all secured the valve walls buckled in three areas.The valve was removed, the aortic annulus was enlarged and a new 23mm inspiris valve was implanted.The patient required a full sternotomy incision and extended pump time.

• 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: 14021426
• MDR Text Key: 288691886
• Report Number: 14021426
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Sex: Female