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

Model Number 11500A

Device Problems Calcified (1077); Degraded (1153); Insufficient Information (3190); Patient Device Interaction Problem (4001); Device Stenosis (4066)

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

Event Date 11/01/2023

Event Type  Injury  

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 learned through implant patient registry that a patient with a 21mm 11500a aortic valve was explanted after an implant duration of 4 years, 9 months due to unknown reason.The explanted valve was replaced with a 23mm 11500a valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

Updated sections: d4 expiration date, h6 type of investigation, investigation findings, and investigation conclusions.The device history record 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.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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed to the event.

Event Description

It was learned through implant patient registry and investigation that a patient with a 21mm 11500a aortic valve was explanted after an implant duration of 4 years, 9 months due to calcification with degeneration and stenosis.The explanted valve was replaced with a 23mm 11500a valve.

Event Description

It was learned through implant patient registry and investigation that a patient with a 21mm 11500a aortic valve was explanted after an implant duration of 4 years, 9 months due to subannular pannus, stenosis, and degeneration.The patient presented with shortness of breath.The explanted valve was replaced with a 23mm 11500a valve.Per medical records, the patient presented with unstable angina and workup revealed nstemi and elevated prosthetic aortic valve gradient with valve area of.8cm2.She underwent cabg x1 and redo avr and aortic root enlargement with gelweave graft.Intraoperatively there was a thick subannular pannus which was causing significant narrowing of the orifice area.This was excised, and root enlargement performed.(valve and subvalvular pannus was sent to pathology) a 23mm 11500a was implanted and post tee showed no paravalvular aortic valvular regurgitation and mean gradient of 4mmhg.The patient was stable at the end of the procedure and discharged on pod #9.

Manufacturer Narrative

Updated sections: b5, b7, g3, g6, h6, health effect - clinical code, and device code(s).

Manufacturer Narrative

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.Through further investigation, it was determined that the root cause of this event was most likely due to patient related factors.

Manufacturer Narrative

H3: customer report of calcification and degeneration were confirmed.Report of stenosis was unable to be confirmed through visual observation.X-ray demonstrated minimal calcification on leaflet 1 and band deformed around leaflet 3.Commissure 3 appeared bent outward and cocr band remained intact; the vfit band does not appear expanded.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 2 at the inflow aspect.Host tissue on the stent circumference was minimal at the outflow aspect.A white thread, approximately 36mm long, was found extending from the sewing ring around leaflet 3 near commissure 1 on the outflow aspect.Suture hole was not visible at this region.Two white threads, approximately 21mm and 27mm long, were found extending from the sewing ring cloth around commissure 2 on the outflow aspect where one of the cut cloth was located.Sewing ring cloth had multiple cuts around the valve.Wireform was exposed at commissure 3 on the outflow aspect.

• Brand Name: EDWARDS 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: 18338385
• MDR Text Key: 330667150
• Report Number: 2015691-2023-18429
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)200207
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2024

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 Expiration Date: 02/07/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 01/26/2024; 02/12/2024; 03/08/2024; 04/11/2024
• Supplement Dates FDA Received: 01/15/2024; 01/31/2024; 03/07/2024; 04/02/2024; 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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: 73 YR
• Patient Sex: Female