MAUDE Adverse Event Report: Edwards Lifesciences Carpentier-Edwards Perimount Magna Ease Pericardial Bioprosthesis; Replacement Heart-Valve

Model Number	3300TFX27MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury

• Brand Name: Carpentier-Edwards Perimount Magna Ease 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: jason reves ; 1 edwards way; mle fl2 - m2202l; irvine, CA 92614 ; +1(949)250-3859
• MDR Report Key: 50739915
• Report Number: 2015691-2026-18486
• Device Sequence Number: 10599878
• Product Code: DYE
• UDI-Device Identifier: 00690103176162
• UDI-Public: (01)00690103176162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Device Expiration Date: 12/12/2020
• Device Model Number: 3300TFX27MM
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 12/13/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 79 YR
• Patient Sex: Male