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

Model Number	280025MM
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Insufficient Information (4580)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 25mm 2800 pericardial aortic valve underwent valve-in-valve intervention after an implant duration of nine (9) years, six (6) months due to unknown reasons.The tavr procedure was performed with a 26mm 9750tfx transcatheter valve.
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, b5, b7, 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.
Event or Problem Description
It was reported that a patient with a 25mm 2800 pericardial aortic valve underwent valve-in-valve intervention after an implant duration of nine (9) years, six (6) months due to aortic stenosis.The patient initially presented with fatigue and exercise intolerance.The tavr procedure was performed with a 26mm 9750tfx transcatheter valve.The patient was stable post procedure and then discharged home.
Additional Manufacturer Narrative
Stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.A definitive root cause is unable to be determined, however, patient and/or procedural factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT RSR 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: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21435671
• Report Number: 2015691-2025-01222
• Device Sequence Number: 17294204
• Product Code: DYE
• UDI-Device Identifier: 00690103021677
• UDI-Public: (01)00690103021677(17)190216
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 02/16/2019
• Device Model Number: 280025MM
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 04/09/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/21/2025; 04/09/2025
• Date Device Manufactured: 02/17/2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female