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

Model Number 11500A

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The subject device is not available for evaluation as currently 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

Edwards received notification that a patient with an inspiris resilia valve model 11500a has been placed under consideration for a re-do intervention after an implant duration of approximately 4 years and 6 months due to structural valve deterioration.

Manufacturer Narrative

Updated section b4 (date of this report), g3 (date received by manufacturer), h6 (investigation findings) and h6 (investigations conclusions).The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Manufacturer Narrative

Corrected data: b5 initially it was reported that this inspiris resilia valve model 11500a was placed under consideration for a re-do intervention after an implant duration of approximately 4 years and 6 months due to structural valve deterioration.However, as per new information received, this event is no longer considered as reportable.After performing further patient tests, it was determined that there was no malfunction of the aortic valve.The patient was experiencing systolic anterior motion (sam).Sam of the mitral valve may occur after mitral valve repair or replacement.It is typically due to redundant native leaflet tissue and may result in left ventricular outflow obstruction.This may require additional leaflet resection or a mitral valve replacement.As there is no evidence that the mitral valve involved is an edward's device, and there is no allegation of malfunction against the aortic valve, this event is no longer considered as reportable and this correction is being submitted.

Event Description

Edwards received notification that a patient with an inspiris resilia valve model 11500a was placed under consideration for a re-do intervention after an implant duration of approximately 4 years and 6 months due to structural valve deterioration.However, additional information was received and it was found that there was no failure of the edwards device.The patient was experiencing systolic anterior motion (sam) of the mitral valve that was being monitored.There was no information suggesting that the mitral valve was an edwards valve.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 15950289
• MDR Text Key: 305162780
• Report Number: 2015691-2022-09771
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention