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

Model Number 11500AJ

Device Problems Calcified (1077); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001); Device Stenosis (4066)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Tachycardia (2095)

Event Type  Injury  

Manufacturer Narrative

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 reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that a 19mm 11500aj aortic valve was explanted after an implant duration of one (1) year, three (3) months due to aortic stenosis secondary to calcification and leaflet immobility.The patient presented with palpitations, shortness of breath, atrial tachycardia, and atrial fibrillation.The device was explanted and decalcification and aortic root enlargement with nicks procedure were performed, and a larger size 21mm 11500aj valve was implanted in replacement.The patient status was reported as 'recovered'.Per the reported information, the patient underwent catheter ablation at a local hospital for the symptoms presented but continued to have palpitations and shortness of breath in sinus rhythm.Subsequent tte showed increased aortic valve pressure gradient and mitral regurgitation.The patient was then referred to the hospital.Tee revealed increased blood flow velocity and pressure gradient, calcification, and restricted opening were observed in the aortic valve, especially immobility of the leaflet corresponding to ncc.Possibility of patient-prosthesis mismatch was also suspected.Severe mr, moderate tr, and moderate pulmonary hypertension were also detected.At the explant surgery of this 19mm 1150aj valve, mitral valve replacement with a non-edwards valve and tricuspid valvuloplasty with a 26mm 6200t tricuspid ring were simultaneously performed.Upon the valve explant, a slight pannus was observed in circumference of the valve at the inflow aspect.There was residual calcification in the patient's aortic annulus that remained at the initial implant surgery.The surgeon placed a suture as a marker to the leaflet corresponding to ncc that showed leaflet immobility in the preoperative tee.Per image evaluation, mildly elevated trans-aortic velocity and gradients are documented in the setting of nearly normal bioprosthesis leaflet appearance and opening, mild systolic narrowing of the lvot, and normal aortic root size.Pressure recovery and possible moderate prosthesis-patient mismatch are probably the dominant contributors to elevated velocity and gradients; mild subvalvular lvot obstruction also could be playing a role.

Manufacturer Narrative

Patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event cannot be conclusively determined with the available information.However, the event observed in this case was likely due patient and/or procedural related factors.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

Manufacturer Narrative

Customer report of stenosis, calcification, and leaflet immobility were unable to be confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 2 on the inflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Sewing ring had multiple cuts around the valve and wireform was exposed on all three commissure.A black suture thread remained attached to the sewing ring around leaflet 2.Suture holes were visible around the sewing ring.

Manufacturer Narrative

Customer report of stenosis, calcification, and leaflet immobility were unable to be confirmed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.No calcification was detected through x-ray analysis.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 2 on the inflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Sewing ring had multiple cuts around the valve and wireform was exposed on all three commissure.A black suture thread remained attached to the sewing ring around leaflet 2.Suture holes were visible around the sewing ring.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18237889
• MDR Text Key: 329375865
• Report Number: 2015691-2023-17793
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103198867
• UDI-Public: (01)00690103198867(17)260323
• 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: 03/15/2024

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 Model Number: 11500AJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 02/02/2024; 03/14/2024
• Supplement Dates FDA Received: 01/03/2024; 02/07/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 54 KG