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

Model Number	6900PTFX
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient with a 29mm 6900ptfx mitral valve underwent a valve-in-valve procedure after an implant duration of 11 years, 7 months due to stenosis.The patient presented with heart failure.The procedure was initially performed with a 29mm 9600tfx transcatheter valve however, the surgery was aborted and the transcatheter valve was not implanted in the patient.The patient was in stable condition post procedure and being evaluated for septal alcohol ablation.Per reporter, the procedure was initially performed with a 29mm 9600tfx transcatheter valve.The surgical team attempted to perform a lampoon procedure; however, it was determined that the anterior mitral leaflet (aml) was not successfully lacerated.The team decided to abort the surgery after 4.5 hours and evaluate the patient for septal alcohol ablation.The patient was in stable condition post procedure.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (investigation findings, investigation conclusions).Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Svd commonly occurs with a considerably increased rate after 10 years.Prior investigations and extensive literature review have shown that it is predominantly related to patient factors and implant duration rather than to manufacturing issues.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely cause is patient factors, including an implant duration of 10 or more years.The subject device is not available for evaluation as it remains implanted in the patient.A device history record (dhr) review is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.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.H11: corrected data: corrected section h6 (type of investigation).
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated section b3, b5, h6 (health effect - impact code).
Event or Problem Description
It was reported that a patient with a 29mm 6900ptfx mitral valve underwent a valve-in-valve procedure after an implant duration of 11 years, 7 months due to stenosis.The patient presented with heart failure.The procedure was initially performed with a 29mm 9600tfx transcatheter valve however, the surgery was aborted and the transcatheter valve was not implanted in the patient ((b)(6) 2025).The patient was in stable condition post procedure and being evaluated for septal alcohol ablation.The valve-in-valve procedure was later performed with a 29mm 9600tfx transcatheter valve ((b)(6) 2025).Per the rep, the procedure was initially performed with a 29mm 9600tfx transcatheter valve (10/20/25).The surgical team attempted to perform a lampoon procedure, however, it was determined that the anterior mitral leaflet (aml) was not successfully lacerated.The team decided to abort the surgery after 4.5 hours and evaluate the patient for septal alcohol ablation.The patient was in stable condition post procedure.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23512057
• Report Number: 2015691-2025-09166
• Device Sequence Number: 18611212
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)151114
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 6900PTFX
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 12/16/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2011
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female