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

Model Number	6900PTFX
Medical Device Problem Codes	Gradient Increase (1270); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Thrombosis/Thrombus (4440)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
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.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
Through implant patient registry and investigation, it was learned that a 31mm 6900ptfx mitral valve was explanted after an implant duration of 1 year, 4 months due to valve thrombosis causing mitral stenosis.Blood cultures were negative.Patient presented with shortness of breath.The explanted valve was replaced with a 33mm 6900ptfx valve.The patient was stable.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
Added information to d4, h4, h6.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.' thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.There may be cases of incidental finding by imaging (echocardiography and/or ct scan) of subclinical leaflet thrombosis (halt) where the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The most likely cause is patient factors.
Additional Manufacturer Narrative
Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
Through implant patient registry and medical records, it was learned that a 31mm 6900ptfx mitral valve was explanted after an implant duration of 1 year, 4 months due to prosthetic valve endocarditis.The explanted valve was replaced with a 33mm 6900ptfx valve.The patient tolerated the procedure well and was discharged on pod# 12.Per medical records, the patient presented with shortness of breath.Blood cultures were negative, however, tee revealed mobile vegetations on the bioprosthetic mitral valve leaflets creating burden and resulting in severe mv stenosis.The patient underwent redo mvr utilizing a 33mm 6900ptfx ce perimount plus valve.The patient tolerated the procedure well with no apparent complications.Postoperatively, he transported to intensive care unit intubated, stable condition.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 16882154
• Report Number: 2015691-2023-12811
• Device Sequence Number: 20648452
• Product Code: DYE
• UDI-Device Identifier: 00690103163612
• UDI-Public: (01)00690103163612(17)240921
• 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: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2023

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: 09/21/2024
• Device Model Number: 6900PTFX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/21/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/20/2023; 07/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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 Age: 73 YR
• Patient Sex: Male