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

Model Number	2700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/12/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The heart is a multivalvular system with heart valves function to promote coordinated forward blood flow during the cardiac cycle.Repairing or replacing one valve might affect the function of another valve by changing the heart structure and/or the hemodynamics.Additional unplanned intervention might be required to restore the normal forward blood flow.In this case, the patient developed severe mitral regurgitation after the implant of the 2700 aortic valve and underwent unplanned mitral valve ring repair.There has been no indication or evidence of a device malfunction and/or deficiency that may have caused or contributed to this event.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.There were no issues identified that would have impacted this event.The root cause cannot be conclusively determined; however, there may have been patient and/or procedural-related factors that contributed to this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.
Event or Problem Description
Through the medical records, edwards learned that a patient developed severe mitral regurgitation after the implantation of the 23mm 2700 aortic valve and underwent an unplanned mitral valve repair with a 26mm cosgrove band.The patient had a history of bicuspid aortic valve s/p repair at age 5, and a-fib.He presented with severe as, dilated aortic root with cad approximately 40 years later.The patient underwent a bentall procedure with a 28mm hemashield graft and avr with a 23mm 2700 valve, cabg, and cox-maze procedure.The procedure was complicated with postoperative severe mitral regurgitation, so he was placed back on bypass, and a mitral valve repair was 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
• MDR Report Key: 11405786
• Report Number: 2015691-2021-01641
• Device Sequence Number: 19958905
• Product Code: DYE
• UDI-Device Identifier: 00690103021608
• UDI-Public: 00690103021608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 04/20/2021

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: 12/31/2009
• Device Model Number: 2700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/20/2021
• 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: 45 YR