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

Model Number	2800TFX23MM
Medical Device Problem Codes	Gradient Increase (1270); Difficult to Open or Close (2921); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Syncope/Fainting (4411)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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 23mm 2800tfx aortic valve underwent a valve-in-valve procedure after an implant duration of four (4) years, seven (7) months due to aortic stenosis with an approximate gradient of 50mmhg.Two leaflets were noted to be nonfunctional.The patient initially presented with dyspnea, fatigue and syncope.The tavr procedure was performed with a 23mm 9750tfx transcatheter valve.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6 the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.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 chronic kidney disease (ckd), hyperlipidemia (hld) and coronary artery disease (cad).
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6.
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 four (4) years, seven (7) months due to severe aortic stenosis with an approximate gradient of 50mmhg.Two leaflets were noted to be nonfunctional.The patient presented dyspnea, fatigue and syncope.The tavr procedure was performed with a 23mm 9750tfx transcatheter valve.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17376888
• Report Number: 2015691-2023-14780
• Device Sequence Number: 17813731
• Product Code: DYE
• UDI-Device Identifier: 00690103194098
• UDI-Public: (01)00690103194098(17)220728
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2023

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
• Device Expiration Date: 07/28/2022
• Device Model Number: 2800TFX23MM
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 09/08/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/25/2023; 09/19/2023
• Date Device Manufactured: 07/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female