MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	8300AB21
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional 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 or Problem Description
It was reported that a patient with a 21mm 8300ab intuity valve was placed under evaluation for valve-in-valve intervention after an implant duration of six (6) years, two (2) months due to unknown reasons.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b1, b2, b4, b5, g3, g6, h2, h6.
Event or Problem Description
It was reported that a patient with a 21mm 8300ab intuity valve underwent valve-in-valve intervention after an implant duration of six (6) years, three (3) months due to aortic stenosis and regurgitation.The tavr procedure was performed with a 23mm non-edwards transcatheter valve.The patient left the procedure in stable condition.
Additional Manufacturer Narrative
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 and/or procedural factors likely caused or contributed.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: 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: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20453018
• Report Number: 2015691-2024-07842
• Device Sequence Number: 20963448
• Product Code: LWR
• UDI-Device Identifier: 00690103194487
• UDI-Public: (01)00690103194487(17)211108
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2024

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 Expiration Date: 11/08/2021
• Device Model Number: 8300AB21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 11/25/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/08/2024; 11/28/2024
• Date Device Manufactured: 11/09/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female