MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART-VALVE

Device Problems Calcified (1077); Gradient Increase (1270); Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards 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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards reviewed article examination of operatively-excised bioprostheses in the mitral valve position to determine the reason for dysfunction in the american journal of cardiology am j cardiol.2022 jun 1;172:98-106.Doi: 10.1016/j.Amjcard.2022.02.029.Pmid: 35569884.A 31 ce valve implanted nine (9) years, nine (9) months, was explanted due to cuspal calcium, paravalvular leak, stenosis, and ring and cusps covered in fibrous tissue.Small calcific deposits are present in each cusp.The dense fibrous tissue from the ring overlays completely 2 of the cusps and partially, 1 cusp.Two cusps were fused at one commissure by the dense fibrous tissue.

Manufacturer Narrative

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.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.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.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.

Manufacturer Narrative

Added information to h10.Image evaluation: article reports of stenosis and fibrous tissue were confirmed through observed host tissue overgrowth in image evaluation.Reports of cuspal calcium and paravalvular leak were unable to be confirmed through image evaluation.One color photo obtained from article depicted inflow and outflow aspects of valve and several cut off fragments of the valve sewing ring.X-ray analysis is required for calcification evaluation.Valve appeared to have heavy host tissue overgrowth encroaching over the leaflets and stent circumference on the outflow aspect.A majority of the sewing ring appeared cut off from the valve.The host tissue overgrowth also appeared to fuse all three leaflets at two of three commissures on the outflow aspect.The heavy host tissue overgrowth would have restricted leaflet mobility and led to stenosis.

• Brand Name: NI
• Type of Device: REPLACEMENT HEART-VALVE
• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17112453
• MDR Text Key: 317055372
• Report Number: 2015691-2023-13641
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 08/04/2023
• Supplement Dates FDA Received: 07/10/2023; 08/04/2023
• 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: 66 YR
• Patient Sex: Male