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

Model Number 11500A

Device Problems Calcified (1077); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient with a 19mm 11500aj aortic valve was explanted after an implant duration of two (2) years and eight (8) months due to aortic stenosis.The explanted valve was replaced with a non-edwards mechanical valve.The patient status was reported as recovered.Per the surgeon, the aortic stenosis was observed within approximately six (6) months after the valve implant, and the patient was followed up.The surgeon also commented that upon the valve explant, pannus growth encroached onto the valve.

Manufacturer Narrative

H10: additional narratives.Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H11.Additional narrative: updated h3 and h6 per new information received.H3: product evaluation: customer report of stenosis was confirmed through observed host tissue overgrowth.Heavy host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 6mm on leaflet 3 at the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 at the outflow aspect.Host tissue overgrowth on the stent circumference was moderate at both the inflow and outflow aspects.Host tissue overgrowth fused leaflets 2 and 3 by approximately 2mm at commissure 3 on the outflow aspect.Host tissue overgrowth restricted leaflet mobility and led to stenosis.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated minimal calcification on the host tissue overgrowth encroaching over leaflet 2.All three leaflets were thickened and swollen at the free margins near the commissures.Multiple sutures remained attached to the sewing ring around the valve.

Manufacturer Narrative

The most likely cause is patient factors.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• 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: 18791336
• MDR Text Key: 336363207
• Report Number: 2015691-2024-01387
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 53 KG