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

Model Number	6900PTFX27
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 27mm 6900ptfx valve in the mitral position underwent a valve-in-valve procedure after and implant duration of 8 years, 5 months due to thrombus and/or pannus causing moderate stenosis.The tmvr was performed with a 29mm 9755rsl transcatheter valve.Per medical records, tee on (b)(6) 2023 noted to have leaflet thrombosis and was started on coumadin.Then, tee ((b)(6)2024) showed moderate-severe bioprosthetic valve stenosis secondary to thrombus/pannus formation.The patient presented with acute diastolic heart failure and cardiogenic shock.The patient is a 59 y.O.Female with history of mvr(2016), severe tr, heart failure, biventricular failure, nicm and hfref (ef 40%), copd, ckd stage 3, htn, hld, nsvt s/p icd and af on warfarin, chronic thrombocytopenia.
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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, 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.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.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.The most likely cause is patient factors.Pannus is a non-immune inflammatory reaction of the body to the implanted prosthesis, characterized by proliferation of fibroelastic tissue and collagen, with a starting point in the suture area and subacute or chronic centripetal evolution.Pannus can have both beneficial and harmful effects depending on the amount of growth and location.A small amount of host tissue growth over the suture line is expected and is needed to form a non-thrombogenic surface and complete the healing process after device implantation.In contrast, an excessive amount of pannus growth can cause nonstructural dysfunction that may require intervention.Host tissue growth can extend onto the cusp surfaces leading to thickening of the cusps, cusp retraction or curling, leaflet immobility, and/or abnormal coaptation, potentially resulting in valvular regurgitation, elevated gradients, and/or stenosis.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.Pannus/host tissue is most likely due to patient factors and is unlikely to be related to a manufacturing non-conformance.The most likely root cause is patient factors.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6, h11.H11: corrected data: this is a duplicate report and was already submitted under mfr # (b)(4).

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20071178
• Report Number: 2015691-2024-06455
• Device Sequence Number: 3048481
• Product Code: DYE
• UDI-Device Identifier: 00690103163599
• UDI-Public: (01)00690103163599(17)190614
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/03/2024

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: 06/14/2019
• Device Model Number: 6900PTFX27
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 10/03/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/03/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2015
• 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; Hospitalization; Life Threatening
• Patient Sex: Unknown