MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	3000TFX
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	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.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 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 it was learned a 25mm 3000tfx aortic valve implanted three (3) years, two (2) months, was explanted due to unknown reasons.The explanted device was replaced with a 25mm 11060a aortic valved conduit.The patient also underwent mitral valve replacement with a 29mm 11400m mitral valve during the operation.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.
Event or Problem Description
Through implant patient registry and medical records, it was learned a 25mm 3000tfx aortic valve implanted three (3) years, two (2) months, was explanted due to mssa endocarditis.The explanted device was replaced with a 25mm 11060a aortic valved conduit.The patient also underwent mitral valve replacement with a 29mm 11400m mitral valve during the operation.Patient tolerated the procedure well and was transferred to icu in stable condition.Per medical records, patient presented a headache followed by fever, confusion, and diaphoresis.Preoperative tee found that there is severe thickening of the left coronary cusp, right coronary cusp and noncoronary cusp of the aortic valve.Patient treated with iv antibiotics.Blood cultures grew mssa.Recent embolic cva with bleeding and was left with significant ischemic changes/necrosis that will necessitate amputation of areas of the 4 extremities.Tee demonstrated the bioprosthetic aortic valve is extremely infected and has large and highly mobile vegetations attached to the aortic and ventricular aspects of the prosthesis with a small pvl noted along the lateral aspect of the prosthesis (3:00 in the short axis plane).The patient underwent redo cabg and native mitral valve replacement with implant of a 29mm 11400m mitral valve.The 25mm 3000tfx aortic valve was explanted and replaced with a 25mm 11060a aortic valved conduit.The procedure tolerated the procedure well and was transferred to the icu in stable condition.Patient was discharged from the hospital on pod # 36.
Additional Manufacturer Narrative
Added information to b5, b6, b7, h6.H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Additional Manufacturer Narrative
A device history record (dhr) review was not performed, as no information regarding a device failure mode was provided.Furthermore, 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 device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, a definitive root cause cannot be conclusively determined.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC 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; irvine, CA 92614 ; 9492501605
• MDR Report Key: 20887198
• Report Number: 2015691-2024-09398
• Device Sequence Number: 8675892
• Product Code: DYE
• UDI-Device Identifier: 00690103163667
• UDI-Public: (01)00690103163667(17)230315
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2024
• 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): 02/06/2025

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: 03/15/2023
• Device Model Number: 3000TFX
• 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: 11/16/2024
• Supplement Date Received by Manufacturer: 01/04/2025; 01/13/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/13/2025; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2019
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male