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

Model Number	2700
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	07/26/2023
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
Through implant patient registry it was learned that a patient with a 25mm 2700 valve underwent a valve-in-valve procedure after an implant duration of 5 (five) years, 10 months due to unknown reasons.The tavr was performed with a 26mm 9755rsl transcatheter valve.Patient was in recovery post procedure.
Additional Manufacturer Narrative
Updated section (b5, g3, h6 (clinical code, type of investigation code and device code).
Event or Problem Description
Through implant patient registry it was learned that a patient with a 25mm 2700 valve underwent a valve-in-valve procedure after an implant duration of 5 (five) years, 10 months due to regurgitation.The patient was presented with shortness of breath, heart failure, and was in cardiogenic shock.The tavr was performed with a 26mm 9755rsl transcatheter valve.Patient was discharged on pod# 5.
Additional Manufacturer Narrative
Aortic regurgitation (ar) in bioprosthetic heart valves, also known as aortic insufficiency, occurs when the valve does not close properly in diastolic phase, which results in retrograde flow of blood into the left ventricle.Trivial or trace to mild amounts of ar are not unusual post operatively in bioprosthetic valves.This is usually tolerated by the patients.If the regurgitation worsens or becomes symptomatic, reoperation may be necessary.Edwards conducts manufacturing and inspection tests to ensure optimum functionality of each valve prior to final distribution.Such tests used to evaluate if edwards valves meet specification include forward flow testing to determine the pressure gradient across the open valve and a coaptation test under constant hydrostatic back pressure to visually evaluate the coaptation of the leaflets.The root cause of this event cannot be conclusively determined with the available information.The subject device is not available for evaluation, as it remains implanted 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.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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT AORTIC 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 ; 9492500222
• MDR Report Key: 17654891
• Report Number: 2015691-2023-15583
• Device Sequence Number: 7370841
• Product Code: DYE
• UDI-Device Identifier: 00690103021615
• UDI-Public: (01)00690103021615(17)200525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2023

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 Model Number: 2700
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 10/19/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/01/2023; 10/22/2023
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male