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); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Thickening of Material (4056)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/18/2023

Event Type  Injury  

Event Description

Edwards received notification that this valve 11500a21 implanted in aortic position was explanted due to valve thrombosis one year after implantation.The patient was put on apixaban and presented with a first episode of transient ischemic attack (tia) 1 year and 5 months after implantation, after cpr (cardiopulmonary resuscitation) it was decided to take an anticoagulant treatment with warfarin.Acetylsalicylic acid for 3 months with an international normalised ratio (inr) objective between 2 and 3.It was observed on tte and toe and scan thickened anteroright cusp, somewhat restricted movement and good mobility of the other leaflets, gradient of 45mmhg and leakage.Patient presented with shortness of breath.A 11500a23 was implanted in replacement.During implant it was also observed pannus on the ventricular side, immobilizing the basal half of the 3 cusps.As reported, after the surgery a bundle branch block on surface ecg without conduction disturbance was noticed.Reportedly, patient was noted as to be discharged home.

Manufacturer Narrative

Additional manufacturer narrative: as reported, the device was not available for return because it was sent to hospital lab for additional testing.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 this valve 11500a21 implanted in aortic position was explanted due to pannus.Before pannus was observed, valve thrombosis was suspected as root cause but was ruled out.As reported, fourteen (14) months after implant, elevation of gradients was noticed.The patient was put on eliquis (apixaban) and presented with a first episode of tia (transient ischemic attack) one (1) year and five (5) months after implantation, after cpr (cardiopulmonary resuscitation) it was decided to take an anticoagulant treatment with warfarin.Kardegic (acetylsalicylic acid) for 3 months with an inr objective between 2 and 3.It was observed on tte and toe and scan thickened antero right cusp, somewhat restricted movement and good mobility of the other leaflets, gradient of 45mmhg and leakage.Patient presented with shortness of breath.A 11500a23 was implanted in replacement.During implant pannus was noticed on the ventricular side, immobilizing the basal half of the 3 cusps.As reported, after the surgery a bundle branch block on surface ecg without conduction disturbance was noticed.Reportedly, patient was noted as to be discharged home.

Manufacturer Narrative

Correction: h6 (health effect - clinical code): "4440 - thrombosis/thrombus" and "4446 - heart failure/congestive heart failure" codes removed and h6 (device code)"2993 - adverse event without identified device or use problem" removed.Added information to section a2 (date of birth), a4, b5, b7, d4 (expiration date), h4 (device manufacturer date), h6 (health effect - clinical code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: the device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The device was not returned for evaluation, therefore customer report of thrombosis could not be confirmed by product evaluation.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device related to a manufacturing deficiency.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The most likely cause is patient factors.

• 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 ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18422534
• MDR Text Key: 331665461
• Report Number: 2015691-2023-18832
• 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
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• 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: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 51 KG