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

Model Number 11500A

Device Problem Gradient Increase (1270)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported a patient with a 25mm 11500a valve implanted in the aortic position developed a high gradient after an implant duration of approximately three years, eight months.The patient was placed back on doac medication for 8 weeks and will repeat tte at that time.Per information received: the patient doing well for three years on doac medications post avr.The patient stopped doac medications.The patient was off anticoagulation for the past 6 to 7 months.Doac medication restarted for 8 weeks and then repeat tte to see if gradients go down.If gradients do not decrease after restarting doac, be considered for viv.Not positive this is as; may be possibly laminated thrombus that developed while off anticoagulation past 6-7 months.Additional information received indicates that the patient underwent a tavr procedure and received a 26mm 9750tfx transcatheter valve.

Manufacturer Narrative

H10: additional manufacturer narrative: the subject device is not available for evaluation, as it remains implanted in the patient.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Engineering evaluation summary: high gradients can occur early or late in the lifetime of a prosthetic valve.When it occurs early after valve replacement, it is typically a result of pressure recovery, patient-prosthesis mismatch, and/or sub-valvular or supravalvular obstruction.Measurement error, a high-flow state, prosthesis dysfunction, and pannus overgrowth can cause late high gradients after aortic valve replacement.Prosthesis dysfunction is most likely related to patient/procedural factors, and not to manufacturing non-conformances, which most likely would be identified intraoperatively or early post implant.A definitive root cause cannot be conclusively determined; however, patient and factors likely caused or contributed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17674463
• MDR Text Key: 322596973
• Report Number: 2015691-2023-15694
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)210702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Date Device Manufactured: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male