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

Model Number	6900PTFX25
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through the investigation of another complaint [(b)(4)] that a patient underwent mitral valve replacement with a 25mm 6900ptfx pericardial mitral valve that was complicated by chordae tendinae rupture and pvl.Urgent redo sternotomy was performed after an unknown implant duration in order to perform the repair.
Additional Manufacturer Narrative
H11: 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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Paravalvular/perivalvular leak (pvl) refers to blood flowing through a channel between the sewing ring of the implanted valve and the cardiac tissue due to an insufficient seal of the valve to the annulus.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl, as the bioprosthesis may not seat properly after debridement.Technique related factors during implantation, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may also create difficulty seating the bioprosthetic valve, resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is insufficient information available regarding patient or procedural factors known to cause or contribute to pvl.Therefore, a definitive root cause cannot be conclusively determined.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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 ; 9492503859
• MDR Report Key: 23977640
• Report Number: 2015691-2026-10203
• Device Sequence Number: 10608857
• Product Code: DYE
• UDI-Device Identifier: 00690103163582
• UDI-Public: (01)00690103163582(17)180316(11)140317
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 03/16/2018
• Device Model Number: 6900PTFX25
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 03/17/2014
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female