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

Model Number	6900PTFX
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Jam (2983)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Patient called via the patient support center, that his 33mm 6900ptfx mitral valve implanted four (4) years was explanted and replaced with a non-edwards mechanical valve due to a leak.The patient reports 1.5 years after initial avr surgery he saw a hematologist for new onset weakness and was treated for anemia.Echo in 01/2023 revealed the valve leak.11 months later he underwent redo avr with a non-edwards mechanical valve.The patient requested a call from our physicians to further discuss his concerns, and edwards surgeon spoke with the patient.
Additional Manufacturer Narrative
The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
Additional Manufacturer Narrative
Devices are typically explanted or disabled because they are not functioning optimally.It may be reported as but not limited to; stenosis, increased/high gradient, regurgitation, transvalvular leak, thickened leaflet, leaflet tear, immobility, restriction, and/or unspecified svd or nsvd.Leaflet immobility or leaflet restriction may be attributed to structural valve deterioration (svd) and/or non-structural valve dysfunction (nsvd).Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.Nsvd is defined as any abnormality not intrinsic to the valve itself that results in dysfunction of the prosthetic valve.The term nsvd refers to problems that are not directly related to failing valve components, yet it results in dysfunction of the prosthetic valve.There can be several causes of early leaflet thickening, such as early thrombosis/halt, early endocarditis or host tissue overgrowth.The most likely cause is patient factors, including possible thrombus (as reported) in addition to a history of coronary artery bypass graft (cabg), type ii diabetes mellitus (dm ii), atherosclerotic heart disease, coronary artery disease (cad) and hyperlipidemia (hld).
Event or Problem Description
Patient called via the patient support center, that his 33mm 6900ptfx mitral valve implanted four (4) years was explanted and replaced with a non-edwards mechanical valve due to a leak.The patient reports 1.5 years after initial mvr surgery he saw a hematologist for new onset weakness and was treated for anemia.Echo in (b)(6) 2023 revealed the valve leak.11 months later he underwent redo avr with a non-edwards mechanical valve.The patient requested a call from our physicians to further discuss his concerns, and edwards surgeon spoke with the patient.Per medical records, patient was on baby aspirin daily.Tee (b)(6) 2022, showed mild transvalvular regurgitation, likely severe mitral stenosis with elevated mean gradient 12mmhg, leaflets appear to be thickened and possible thrombus on leaflet with restricted mobility.No other records provided after tee.Patient had surgery 1 year later for redo mvr.This is a 53-year-old male with a history of mr s/p mvr, cabg x3, laa ligation (2019), chf iv, ischemic cardiomyopathy, steroid induced hyperglycemia, dm ii, atherosclerotic heart disease, coronary artery disease, hyperlipidemia, immune thrombocytopenia, autoimmune hemolytic anemia, evan's syndrome, and tobacco abuse/daily.
Additional Manufacturer Narrative
Added information to b5, e2, e3, e4, h10.
Event or Problem Description
It was learned through receipt of voluntary medwatch form that patient endorsed experiencing anemia and shortness of breath due to failure of implant.Patient had to visit emergency department and required medication.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19090712
• Report Number: 2015691-2024-02778
• Device Sequence Number: 7558619
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: (01)00690103163629(17)201128
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 6900PTFX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/22/2024; 01/12/2026
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/20/2024; 05/23/2024; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2016
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male