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

Model Number	6900PTFX31
Medical Device Problem Codes	Thickening of Material (4056); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the subject device is not available for evaluation, as it remains implanted in the patient.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 learned through implant patient registry and medical records that a patient with a 31mm 6900ptfx mitral valve underwent a valve-in-valve procedure after an implant duration of 4 years, ten months due to thickened leaflets, abnormal leaflet motion, severe mitral stenosis, and regurgitation.Patient presented with heart failure, and shortness of breath.The tmvr was performed with a 29mm 9755rsl transcatheter valve.The patient was discharged pod#1 in stable condition.Per medical records, the patient was presented with fatigue and doe in the setting of nyha class iii hf.Cardiac work up revealed severe prosthetic mitral valve stenosis and mild regurgitation.Tee showed thickened and hyperechoic leaflets with abnormal motion.The patient underwent successful tmvr with no regurgitation, nor pvl.The patient was able to ambulate well and was discharged home on pod #1.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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.Engineering evaluation summary: per (b)(4), devices are typically explanted or disabled because they are not functioning optimally.In some cases, the failure mode is not provided.Other times, 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 thickening may be attributed to structural valve deterioration (svd) and/or non-structural valve dysfunction (nsvd).Per technical summary (b)(4), svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.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.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.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.Per (b)(4) an engineering evaluation 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 use-related issue with a hazardous situation no device-related infection and no evidence of a product failure with regard to design reliability or use error.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• 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; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20286507
• Report Number: 2015691-2024-07315
• Device Sequence Number: 7363106
• Product Code: DYE
• UDI-Device Identifier: 00690103163612
• UDI-Public: (01)00690103163612(17)220826
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 08/26/2022
• Device Model Number: 6900PTFX31
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 91 KG