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

Model Number 11500A

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information is in process.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 an inspiris resilia valve of unknown size likely implanted in the pulmonary position was explanted after an unknown implant duration for unknown reasons.As reported, the patient was young.

Manufacturer Narrative

(device codes, type of investigation, investigation findings, investigation conclusions).Customer report of pannus leading to stenosis was confirmed through evaluation of the provided videos.Video 1 showed the outflow aspect of an implanted valve.Pannus overgrowth was visible over the stent circumference on the outflow aspect.Pannus was also visible when the leaflets were opened.Video showed a ring of pannus overgrowth removed from the inflow aspect of the valve.Video 2 showed the inflow aspect of the explanted valve.Heavy host tissue overgrowth was observed on the stent circumference.Also, it was shown that host tissue overgrowth encroached onto the tissue and into the orifice of all three leaflets leading to stenosis.The device was not returned for evaluation.Attempts to retrieve the device and additional information were unsuccessful.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 a 23mm inspiris resilia valve implanted in the aortic position was explanted after an implant duration of approximately four (4) years and three (3) months due to pannus leading to stenosis.As reported, the patient was "incredibly symptomatic" for recurrent aortic stenosis during the prior 3 months.At explant, it was observed that the valve presented very dense adhesions and severe subvalvular pannus formation caused by an inflammatory response.The pannus had particularly grown under the right and left cusps.The leaflets were in good condition.The valve was replaced with a pulmonary autograph.The patient was discharged home.

Manufacturer Narrative

H10: additional manufacturer narrative: based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.The device was not returned for evaluation, no details regarding what issue warranted the intervention, or what comorbidities the patient had, were provided.Attempts to retrieve the device and additional information were unsuccessful.The cause of the event cannot be determined.Based on the information available, a definitive root cause cannot be conclusively determined.

Event Description

Edwards received notification that a 23mm inspiris resilia valve implanted in the aortic position was explanted after an implant duration of approximately four (4) years and three (3) months due to pannus leading to stenosis.As reported, the patient was "incredibly symptomatic" with shortness of breath for recurrent aortic stenosis during the prior 3 months.At explant, it was observed that the valve presented very dense adhesions and severe subvalvular pannus formation caused by an inflammatory response.The pannus had particularly grown under the right and left cusps.The leaflets were in good condition.The valve was replaced with a pulmonary autograph.The patient was discharged home.

Manufacturer Narrative

The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.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.Pannus can have both beneficial and harmful effects depending on the amount of growth.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.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: 16051538
• MDR Text Key: 306170955
• Report Number: 2015691-2022-10379
• 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,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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
• Date Manufacturer Received: 03/15/2023
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female