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

Model Number 11500A

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Type  Injury  

Event Description

Edwards received notification that a 71year old patient with a 11500a21 valve has been placed under consideration for a valve-in-valve procedure after an unknown implant duration due to hypodense thickening of its leaflets in relation to halt (hyperattenuated leaflet thickening), the right and left 50% and posterior 25%.

Manufacturer Narrative

H10.Additional manufacturer narrative: images were provided and reviewed.The images provided were aligned with the customer's report.The device was not returned to edwards for evaluation as it remains implanted.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 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 11500a21 valve was explanted after approximately two (2) years and three (3) months due to hypodense thickening of its leaflets in relation to halt (hypoattenuated leaflet thickening), the right and left 50% and posterior 25%.The patient presented with dyspnea, deterioration on nyha class ii to iii.During the re-do surgery, reportedly, the inspiris presented no damage, there was no thrombosis, but it was in an inclined position in reference to the patients aortic annulus.This inclination caused a mismatch, and functional stenosis.The inspiris valve was explanted holding it by the cuff, leaving the valve intact so it can be evaluated.A 23mm mechanical valve was successfully implanted as replacement.The patient was recovering well.

Manufacturer Narrative

Added information to section d6 (explant date), e1.Updated section b5, h6 (impact code), h6 (clinical code), h6 (device code), h6 (investigation findings) and h6 (investigations conclusions).The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The most likely cause of the device malposition is procedural factors occurring at the time of implant, including difficult or improper positioning of the device.It is possible that the device malposition contributed to the reported halt.Based on the information provided, a definitive root cause of the reported event cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• 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: 18960989
• MDR Text Key: 338379295
• Report Number: 2015691-2024-02230
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/26/2024
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male