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

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

H3.Device evaluation: the device was returned for evaluation.Customer report of thrombosis was confirmed.X-ray demonstrated wireform and cocr band intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated minimal calcification nodules on leaflet 1.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7 mm on leaflet 3 on the outflow aspect and 4mm on leaflet 2 on the inflow aspect.Host tissue on the stent circumference was heavy at both the outflow and inflow aspects.Thrombotic-like material was observed on the outflow aspect of all three leaflets.Band exposed around the valve in the inflow aspect.H10.Additional manufacturer narrative: 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 11500a19 valve implanted in aortic position was explanted after an implant duration of two (2) years and eleven (11) months due to suspicion of valve thrombosis leading to high gradient (mean 41mmhg, peak 83mmhg, vmax 4,55 m/s) with a patient being symptomatic.Antithrombotic treatment was given after the initial intervention (aspirine) lifelong time.No anticoagulant treatment was given for the suspected thrombosis.Per medical records provided, there was valve degeneration with fibrosis of the right biocuspid and calcification and hypomobility of the non-coronary bicuspid affecting medium-severe stenosis, no evidence of macroscopic leaks.After the valve was explanted white thrombus was observed.The valve was replaced with a 3300tfx23mm valve concomitantly with annulus enlargement with secondo yang technique.The hospital course was free from significant complications.

Manufacturer Narrative

Added information to section h6 (type of investigation, investigation findings and investigation conclusions).Correction h6 (device code): removed code "adverse event without identified device or use problem".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.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.Pannus overgrowth, or host tissue, is considered 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.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 reported type of event is included in the ifu.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 ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18756415
• MDR Text Key: 335932818
• Report Number: 2015691-2024-01209
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/08/2022
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 63 YR
• Patient Weight: 77 KG