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

Model Number 11500A21

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921)

Patient Problem Dyspnea (1816)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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, an appropriate investigation will be performed.

Event Description

Edwards received notification that this (b)(6) y-o patient with an inspiris resilia valve model 11500a21 implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of approx.1 year and 8 months due to degeneration leading to stenosis.The patient presented with dyspnea before the procedure.A mean gradient of 40mmhg and max gradient of 62mmhg and ef 45% were observed on echo.The patient was referred for viv implantation because was considered not suitable for open heart surgery as the patient was a monokidney with a permanent bladder catheter.A 23mm sapien ultra valve was implanted within the edwards surgical device.The patient was discharged from the hospital and was in good condition.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b5, b7, h6 (component codes, device code(s), type of investigation, investigation findings, and investigation conclusions), and h10.H10: stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly, may contribute to stenosis and/or regurgitation.In this case, calcification was indicated.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.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 bioprosthesis from calcifying.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 this 66-y-o patient with an inspiris resilia valve model 11500a21 implanted in the aortic position underwent a valve-in-valve procedure after an implant duration of 2 years and 5 months due to calcific degeneration and leaflet thickening leading to hypomobility, stenosis and moderate regurgitation.The patient presented with dyspnea before the procedure.A mean gradient of 40mmhg and max gradient of 62mmhg and ef 45% were observed on echo.The patient was referred for viv implantation because was considered not suitable for open heart surgery as the patient was a monokidney with a permanent bladder catheter.A 23mm sapien ultra valve was implanted within the edwards surgical device.The patient was discharged from the hospital and was in good condition.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12579502
• MDR Text Key: 275002547
• Report Number: 2015691-2021-05523
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79 KG