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

Model Number	11500A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation, as it remains implanted.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 or Problem Description
It was reported that a patient with a 19mm 11500a aortic valve has been placed under evaluation for a valve-in-valve procedure after an implant duration of 2 years, 2 months due to unknown reason.
Event or Problem Description
It was reported and learned through records that a patient with a 19mm 11500a aortic valve underwent a valve-in-valve procedure after an implant duration of two (2) years, three (3) months due to severe stenosis.The patient presented with acute on chronic hfpef nyha ii.The tavr was performed with a 23mm non-edwards device.The patient was transported to cvu without complications and was discharged on pod #1.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6 (component code, clinical code, device code, type of investigation, investigation findings, investigation conclusions).Stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.A definitive root cause is unable to be determined, however, patient factors likely caused or contributed.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 even.H11: corrected data: b2, h6 (impact code).

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: 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: 20833425
• Report Number: 2015691-2024-09082
• Device Sequence Number: 8638670
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)241014(11)201015
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2024
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female