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

Model Number 11500A

Device Problems Calcified (1077); Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Dizziness (2194); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446)

Event Date 04/17/2023

Event Type  Injury  

Event Description

It was reported that a 25mm aortic valve was explanted and replaced with a non-ew valve after an implant duration of 4 years, 9 months due to severe stenosis and high gradient.The patient presented with hfpef, dyspnea, episodic syncope, dizziness, and a-fib.Per medical records the patient underwent redo-avr and laa exclusion using a clip.The patient was discharged home on pod #7.

Manufacturer Narrative

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 not returned for evaluation, as the device request 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

H3: product evaluation: customer report of stenosis was confirmed through observed calcification and host tissue overgrowth.Report of high gradient was unable to be confirmed through visual observations.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray also demonstrated heavy calcification on all three leaflets.Extrinsic calcific deposits were observed on the inflow surfaces of all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm 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 2mm on leaflet 1 at the outflow aspect.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Serrated mechanical damage marks were observed on the outflow surfaces of leaflets 2 and 3 near commissure 3 and did not penetrate leaflets.Sewing ring was cut off around leaflet 1 near commissure 1 and cut off sewing ring fragment was not returned.The metal band was exposed around leaflets 1 and 3 on the inflow aspect.Wireform was exposed on commissure 3 and around leaflet 2 on the outflow aspect.A suture remained attached to the sewing ring around leaflet 3.The most likely cause is patient factors, including history of bicuspid aortic valve and diabetes mellitus (dm).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: 16896747
• MDR Text Key: 314845954
• Report Number: 2015691-2023-12878
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)190906
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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 Expiration Date: 09/06/2019
• Device Model Number: 11500A
• Device Catalogue Number: 11500A25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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: 50 YR
• Patient Sex: Male