MAUDE Adverse Event Report: Edwards Lifesciences LLC CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC; replacement Heart-valve

Model Number	3300TFX
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
\[redacted]"--- when replacing the aortic valve, the first tissue valve was not functioning properly.It was discovered on tee \[transesophageal echocardiogram]" when trying to come off bypass.Decided by md to replace the valve.Procedure required more time on bypass.Second valve worked properly.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
• Common Device Name: replacement Heart-valve
• Manufacturer (Section D): Edwards Lifesciences LLC; one edwards way; irvine CA 92614
• MDR Report Key: 50053696
• Report Number: 50053696
• Device Sequence Number: 9481422
• Product Code: DYE
• UDI-Device Identifier: 00690103176148
• UDI-Public: (01)00690103176148
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/20/2026
• Report Date (Section F): 07/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3300TFX
• Device Catalogue Number: 3300TFX23MM
• Device Lot Number: 13099759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 84 LB
• Date Report Sent to FDA: 07/20/2026