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

Model Number	6900PTFX
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Thickening of Material (4056)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient with a 33mm 6900ptfx mitral valve underwent a valve-in-valve procedure after an implant duration of seven (7) years and seven (7) months due to unknown reason.The tmvr was performed with a 29mm 9755rsl transcatheter valve.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 (component code, type of investigation, investigation findings, investigation conclusions) 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).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.The instructions for use (ifu) have been reviewed, and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.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.The most likely cause is patient factors, including hyperlipidemia.
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.
Event or Problem Description
It was reported that a patient with a 33mm 6900ptfx mitral valve underwent a valve-in-valve procedure after an implant duration of seven (7) years and seven (7) months due to restricted and thickened leaflets with severe stenosis and regurgitation.The patient presented in acute decompensated heart failure with dyspnea.The tmvr was performed with a 29mm 9755rsl transcatheter valve.Per medical records, following patients redo avr in 2022, patients mitral valve was noted to have stenosis but was left untreated due to complexity of patients av surgery with perioperative cva.Tmvr was attempted on (b)(6) 2024 but was unsuccessful due to technical difficulties.On (b)(6) 2024, the patient underwent a valve-in-valve procedure utilizing 29mm 9755rsl transcatheter valve.The post-operative echo showed no pvl.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS 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: 20702640
• Report Number: 2015691-2024-08696
• Device Sequence Number: 11691174
• Product Code: DYE
• UDI-Device Identifier: 00690103163629
• UDI-Public: (01)00690103163629(17)190104
• 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: 2017
• 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): 12/16/2024

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: 01/04/2019
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 12/10/2024
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2015
• 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: 62 YR
• Patient Sex: Male