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

Model Number 11500A

Device Problems Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  Injury  

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.

Event Description

It was reported a patient with a 21mm 11500a aortic valve implanted in the pulmonary position for ten (10) months, underwent a valve-in-valve procedure due to leaflet motion restricted, stenosis, and mild pulmonary regurgitation.The procedure was performed with a 23mm 9600tfx valve and the patient was in stable condition post-operatively.

Manufacturer Narrative

Per event description, "it was reported a patient with a 21mm 11500a aortic valve implanted in the pulmonary position for ten (10) months, underwent a valve-in-valve procedure due to leaflet motion restricted, stenosis, and mild pulmonary regurgitation." based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.The subject device was unable to be returned for evaluation as it remains implanted.A device history record (dhr) review was performed, and no relevant non-conformances were identified.A lot history review identified no similar complaints.Post-operative pulmonary regurgitation and restricted leaflet motion was unable to be confirmed with the provided medical records (history & physical and echo report).Leaflet immobility or leaflet restriction occurring over time can be attributed to structural valve deterioration and/or nonstructural dysfunction, which can be manifested as regurgitation and/or stenosis.Nonstructural valve dysfunction (nsvd) is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.Based on the information available, a definitive root cause cannot be concluded but patient factors, including patient age, history of tetralogy of fallot, and implant position could have contributed.An edwards defect has not been confirmed.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18651902
• MDR Text Key: 334678057
• Report Number: 2015691-2024-00794
• Device Sequence Number: 1
• Product Code: LWR
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male