MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC 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	06/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a patient with a 29mm 3000tfx aortic valve was explanted after an implant duration of 7 years due to unknown reasons.The explanted valve was replaced with a 27mm 11500a inspiris resilia aortic 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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the complaint investigation was conducted, using evaluation summary (b)(4) and triage level 1, in accordance with tca (b)(4).Due diligence attempts were made to gather additional information regarding a device failure mode, however additional information is not available at this time.Patient medical records were not provided by the hospital for review, or the medical records provided do not clarify the device failure mode.Per the instructions for use (ifu), reoperation/explant are known potential adverse events associated with bioprosthetic cardiac valves and annuloplasty rings.In this case, there is no evidence 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 use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.As such, neither a product risk assessment (pra) nor corrective or preventive actions (capa/scar) are required at this time, per (b)(4).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 LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19670001
• Report Number: 2015691-2024-05122
• Device Sequence Number: 11566079
• Product Code: DYE
• UDI-Device Identifier: 00690103163681
• UDI-Public: (01)00690103163681(17)200803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 08/13/2024

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: 08/03/2020
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2016
• 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; Life Threatening; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male