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

Model Number 11500A25

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.In this case, minimal information regarding this valve replacement procedure was received and attempts to obtain additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been made.The root cause of this event cannot be determined with the available information.However, this event was most likely impacted by the progression of the patient¿s underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.Requests for additional information have been performed.The healthcare provider has neither returned the explanted valve nor provided any additional information at this time.The device was not returned for evaluation.If returned, a supplemental report including the evaluation findings will be submitted.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.

Event Description

It was learned via the patient registry that a patient with a 25mm 11500a pericardial aortic valve underwent a redo aortic valve replacement procedure after an implant duration of four (4) months due to unknown reasons.The explanted valve was replaced with a 23mm 11500a pericardial valve.

Manufacturer Narrative

Updated: b4, g4, h6.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11096523
• MDR Text Key: 224798775
• Report Number: 2015691-2020-15331
• 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,other,use
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR