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

Model Number	2800TFX
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Gradient Increase (1270); Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Calcification is a well-recognized failure mode of bioprosthetic valves.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), and mechanical stress related to the valve's hemodynamic performance.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Although patient factors are believed to play a crucial role in the development in bioprosthetic tissue calcification, the underline mechanism is still not fully understood.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.
Event or Problem Description
It was reported that a patient with a 25mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 6 years, 3 months due to calcification, leaflet thickening, pannus, motion restriction, and severe stenosis.The patient presented with sob.
Event or Problem Description
It was reported that a patient with a 2800tfx 25mm aortic valve is being evaluated for a valve-in-valve procedure after an implant duration of 6 years, 3 months due to calcification, leaflet thickening, pannus, motion restriction, and severe stenosis.The patient presented with sob and a newly reduced ejection fraction of 30%.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, d4 (expiration date), h4 (device manufacturer date), and h6 (type of investigation, investigation findings, and investigation conclusions).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12640898
• Report Number: 2015691-2021-05695
• Device Sequence Number: 17229322
• Product Code: DYE
• UDI-Device Identifier: 00690103194104
• UDI-Public: (01)00690103194104(17)190121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/16/2021

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: 01/21/2019
• Device Model Number: 2800TFX
• Device Catalogue Number: 2800TFX25MM
• 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: 09/20/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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: 37 YR
• Patient Sex: Male