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

Model Number	2800TFX
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, pvl, when severe, can lead to significant morbidity including heart failure and hemolytic anemia.The root cause of this event cannot be conclusively determined with the available information.However, the event, in this case, was most likely impacted by the progression of the patient's underlying valvular disease pathology with or without structural valve deterioration and/or nonstructural dysfunction.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.
Event or Problem Description
It was reported that a patient with a 23mm 2800tfx aortic valve has been placed under evaluation for a valve-in-valve after an implant duration of nine (9) years, seven (7) months due to pvl.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, g3, g6, h2, and h6 (component codes, health effect-impact code, health effect-clinical code, type of investigation, and investigation conclusion).
Event or Problem Description
It was reported that a patient with a 23mm 2800tfx aortic valve underwent a valve-in-valve after an implant duration of nine (9) years, seven (7) months due to mild to moderate pvl.The patient presented with worsening exertional dyspnea.The tavr was performed with a 26mm 9750tfx.The patient was transferred to the cvr unit in stable condition.On pod #3, the patient was discharged home in stable condition.

• 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
• MDR Report Key: 11733309
• Report Number: 2015691-2021-02694
• Device Sequence Number: 4219874
• Product Code: DYE
• UDI-Device Identifier: 00690103194098
• UDI-Public: 00690103194098
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 05/11/2013
• Device Model Number: 2800TFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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: 78 YR