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

Model Number	3000TFX
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
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
It was reported that a patient with a 21mm 3000tfx aortic valve is being worked up for a valve-in-valve procedure after an implant duration of two (2) years, three (3) months due to unknown reason.No other details were provided.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated section h6 (component code, investigation findings, investigation conclusions).Requests for additional information have been performed.The healthcare provider has not provided any additional information at this time.The root cause of this event cannot be determined with the available information.It is unknown if patient and/or procedure related factors may have caused or contributed to this event.There has been no allegation of a product malfunction.The device history record (dhr) was not reviewed as no information regarding a device failure mode was provided.Therefore, a review of manufacturing and/or device component issues that may have contributed to the reported event is unable to be performed.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.If any new information is received, a supplemental report will be submitted accordingly.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA 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: 19127160
• Report Number: 2015691-2024-02924
• Device Sequence Number: 18047653
• Product Code: DYE
• UDI-Device Identifier: 00690103163643
• UDI-Public: (01)00690103163643(17)230326
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 05/20/2024

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: 03/26/2023
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2019
• 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: Life Threatening; Other
• Patient Age: 71 YR
• Patient Sex: Female