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

Model Number	7300TFX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: article: chiou a, ibrahim f, stinis c, simultaneous transcatheter tricuspid viv and mitral viv replacement with lampoon in a patient with early bioprosthetic mv and tv dysfunction from halt, doi: https://www.Jacc.Org/doi/10.1016/s0735-1097%2825%2903911-7.The device was not returned for evaluation, as it remains implanted.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.Refer to mfr report number 2015691-2026-11409 for valve-in-valve tmvr procedure information involving this patient.
Event or Problem Description
Edwards reviewed the literature article, "simultaneous transcatheter tricuspid viv and mitral viv replacement with lampoon in a patient with early bioprosthetic mv and tv dysfunction from halt", (b)(6) 2025.It was learned that a patient with a unknown 29mm edwards magna ease valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after approximately 2 years due to thrombosis/halt and torrential tricuspid regurgitation.The ttvr was performed with a 29mm 9755rsl.Per clinical case, the patient presented with progressive fatigue, shortness of breath, significant volume overload.Pre-operative tee showed an immobile, thickened lateral bioprosthetic mv leaflet leading to severe mr.Short, thickened, immobile bioprosthetic tv leaflets leading to torrential tr.Cardiac ct revealed mv and tv leaflet thrombosis with evidence of halt and reduced leaflet mobility.Anticoagulation therapy was initiated however patient continued to have persistent symptoms and valvular dysfunction and underwent viv.Post-procedure tte showed well seated mv and tv with no residual mr or tr.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: a1, a2 (date of birth), b3, b4, b5, d1, d4 (model number, serial number, expiration date, primary unique device identification), d6a., g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions).Article: chiou, a, ibrahim, f, stinis, c.Simultaneous transcatheter tricuspid viv and mitral viv replacement with lampoon in a patient with early bioprosthetic mv and tv dysfunction from halt.Jacc (2025), doi: https://doi.Org/10.1016/s0735-1097(25)03911-7.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Thrombosis is a condition in which blood coagulates and creates what is commonly known as blood clots.Thrombosis can cause life-threatening conditions requiring immediate medical attention.Bioprosthetic valve thrombosis (bpvt) is one category of bioprosthetic valve dysfunction and is an increasingly recognized complication of tissue valve prosthesis.Bpvt usually occurs late after implantation and can be further categorized into two subcategories: clinical valve thrombosis (cvt) and subclinical valve thrombosis (slt).Clinical valve thrombosis is defined as clinically apparent prosthetic valve dysfunction with the typical finding of an increased transvalvular gradient with a mobile mass/thrombus on the prosthetic heart valve as visualized by echocardiography or multi-detector computed tomography (mdct).Valve thrombosis is a known potential risk associated with the use of bioprosthetic heart valves, which is included in the instructions for use (ifu), and there is no evidence to suggest a manufacturing non-conformance or defect contributed, thus no further evaluation is needed.This event will be included in ongoing monitoring.Based on the information available, the most likely cause is patient factors including patient's history of heart failure and fen-phen use which increases risk for clots.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.H11: corrected data: e1 (contact).
Event or Problem Description
Edwards reviewed the literature article, simultaneous transcatheter tricuspid viv and mitral viv replacement with lampoon in a patient with early bioprosthetic mv and tv dysfunction from halt, april 1, 2025.It was learned that a patient with a 29mm 7300tfx mitral valve, implanted in the tricuspid position, underwent a valve-in-valve procedure after an implant duration of 5 years, 2 months due to thrombosis/halt and torrential tricuspid regurgitation.The ttvr was performed with a 29mm 9755rsl.Per clinical case, the patient presented with progressive fatigue, shortness of breath, significant volume overload.Pre-operative tee showed an immobile, thickened lateral bioprosthetic mv leaflet leading to severe mr.Short, thickened, immobile bioprosthetic tv leaflets leading to torrential tr.Cardiac ct revealed mv and tv leaflet thrombosis with evidence of halt and reduced leaflet mobility.Anticoagulation therapy was initiated however patient continued to have persistent symptoms and valvular dysfunction and underwent valve-in-valve.Post-procedure tte showed well seated mv and tv with no residual mr or tr.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL 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, LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24462522
• Report Number: 2015691-2026-11580
• Device Sequence Number: 21184800
• Product Code: DYE
• UDI-Device Identifier: 00690103186277
• UDI-Public: (01)00690103186277(17)250119(11)210120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2025
• Device Model Number: 7300TFX
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female