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

Model Number	2800TFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 21mm 2800tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 4 years, 7 months due to stenosis.The procedure was performed with a 23mm 9755rsl transcatheter valve.
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 and learned through medical records that a patient with a 21mm 2800tfx aortic valve underwent a valve-in-valve procedure after an implant duration of 4 years, 7 months due to stenosis.The patient presented with heart failure, doe, and ble edema.The procedure was performed with a 23mm 9755rsl transcatheter valve.The patient was discharged pod #2.Per medical records, the patient presented with heart failure characterized by worsening sob, doe, central chest pressure, and slowly worsening swelling in both legs.Echo ((b)(6) 2023) revealed a normally functioning 21mm edwards valve with mild intravalvular regurgitation.The patient was discharged pod #2.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections b5, b7, h6 (health effect - clinical code).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
H11: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (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.The most likely root cause is patient-related factors, including chronic kidney disease and diabetes mellitus.The subject device is not available for evaluation as it remains in the patient.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.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.H11: corrected data: corrected section h6 (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 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: 20026801
• Report Number: 2015691-2024-06278
• Device Sequence Number: 18292912
• Product Code: DYE
• UDI-Device Identifier: 00690103194081
• UDI-Public: (01)00690103194081(17)230928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 09/26/2024

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: 09/28/2023
• Device Model Number: 2800TFX
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 09/16/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2019
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male