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

Model Number	2800TFX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	09/09/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a patient with a 21mm 2800tfx aortic valve was explanted after an implant duration of 3 months due to unknown reason.The explanted valve was replaced with a 23mm 3300tfx valve.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 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 21mm 2800tfx aortic valve was explanted after an implant duration of 3 months due to endocarditis and pvl.The explanted valve was replaced with a 23mm 3300tfx valve.Per records provided, after 3 months after the aortic valve replacement the patient acquired candida prosthetic valve endocarditis.The endocarditis was treated medically; however, it was not able to clear the bacteria in the blood stream.The patient came back to the hospital with a stroke that was treated and was admitted to the hospital.The valve was full of vegetations, there was also pvl.The team suspected that the pvl was coming from the annulus since there was some calcification on it and the valve might have been slightly undersized.The valve was removed and replaced with a 23mm 3300tfx valve.The patient was weaned off the heart-lung machine and decannulated.Protamine was administrated.The patient tolerated the procedure well and was transferred to the icu in a stable condition.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections b5, g3, g6, h2, h6 (clinical code and device code).Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON 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: jason reves ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24688895
• Report Number: 2015691-2026-13506
• Device Sequence Number: 18652524
• Product Code: DYE
• UDI-Device Identifier: 00690103177237
• UDI-Public: (01)00690103177237(17)161203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• 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): 04/21/2026

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: 12/03/2016
• Device Model Number: 2800TFX
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male