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

Model Number	3000TFX
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received information a patient with an edwards magna valve implanted for approximately six years in pulmonary position underwent valve-in-valve procedure due to high gradient.A 26mm s3 ultra transcatheter valve was implanted inside the surgical valve.
Additional Manufacturer Narrative
Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.Attempts to retrieve 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.
Additional Manufacturer Narrative
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.Edwards received information a patient with an edwards magna valve implanted for approximately five (5) years, 10 months, in pulmonary position underwent valve-in-valve procedure due to high gradient.A 26mm s3 ultra transcatheter valve was implanted inside the surgical valve.Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of rings and bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.High gradients can occur early or late in the lifetime of a prosthetic valve.When it occurs early after aortic valve replacement, it is typically a result of pressure recovery, patient-prosthesis mismatch, and/or subvalvular or supravalvular obstruction.Measurement error, a high-flow state, prosthesis dysfunction, and pannus overgrowth can cause late high gradients after aortic valve replacement.Prosthesis dysfunction is most likely related to patient/procedural factors, and not to manufacturing non-conformances, which most likely would be identified intraoperatively or early post implant.A definitive root cause cannot be conclusively determined; however, patient factors and implant position likely caused or contributed.
Event or Problem Description
Edwards received information a patient with a 29mm 3000tfx aortic valve implanted for approximately five (5) years, 10 months, in pulmonary position underwent valve-in-valve procedure due to high gradient.A 26mm s3 ultra transcatheter valve was implanted inside the surgical valve.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15639982
• Report Number: 2015691-2022-08703
• Device Sequence Number: 15047109
• Product Code: DYE
• UDI-Device Identifier: 00690103163681
• UDI-Public: (01)00690103163681(17)200508
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/09/2022

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: 05/08/2020
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• 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; Hospitalization; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female