MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS; REPLACEMENT, HEART-VALVE

Model Number	2800
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 23mm 2800tfx aortic valve, underwent a valve-in-valve procedure after an implant duration of 5 years, 5 months due to stenosis.The procedure was performed with a non-edwards device.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the subject device is not available for evaluation, as it remains implanted in the patient.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.
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.There were no issues identified that would have impacted this event.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 explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The most likely cause is patient factors, including history of coronary artery bypass graft (cabg), coronary artery disease (cad), diabetes mellitus (dm) and hyperlipidemia (hld).
Event or Problem Description
It was reported that a patient with a 23mm 2800tfx aortic valve, underwent a valve-in-valve procedure after an implant duration of 5 years, 5 months due to stenosis.The patient presented with heart failure and shortness of breath.The procedure was performed with a non-edwards device.The patient is stable.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, g3, g6, h2, and h6 (clinical code and type of investigation).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT, HEART-VALVE
• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17731047
• Report Number: 2015691-2023-15872
• Device Sequence Number: 12285223
• Product Code: DYE
• UDI-Device Identifier: 00690103194098
• UDI-Public: (01)00690103194098(17)201207
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: 2800
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/11/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/28/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2016
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female