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

Model Number 11500A

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.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 implanted in an unknown position was explanted after an implant duration no longer than 1 year due to a leaflet tear.No other information was provided.

Manufacturer Narrative

Added information to section h6 (device code(s)), h6 (investigation findings) and h6 (investigations conclusions).Corrected data h6 (device code(s)): "1261 - material fragmentation" code removed.The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The device was not returned for evaluation, therefore customer report of leaflet damaged could not be confirmed by product evaluation.Devices are typically explanted or treated because they are not functioning optimally.In some cases, the failure mode is unknown.Other times, it may be reported as stenosis, increased/high gradient, regurgitation, thickened leaflet; leaflet tear, immobility, restriction, or difficulty coapting.These may be a manifestation of structural valve deterioration (svd) or nonstructural dysfunction (nsvd).Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.Nonstructural valve dysfunction (nsvd) is any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that do not directly involve valve components yet results in dysfunction of the prosthetic valve; such problems can include entrapment by pannus, tissue, or suture, malposition, patient prosthesis mismatch, thrombosis, or technical errors.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Pa definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

Manufacturer Narrative

Upon further investigation review, the conclusion was updated to to: a definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• 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: 18099510
• MDR Text Key: 327699469
• Report Number: 2015691-2023-17338
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 12/20/2023
• 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): Required Intervention; Life Threatening; Hospitalization