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

Model Number	6900PTFX29
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 29mm 6900ptfx pericardial mitral valve was placed under consideration for a valve-in-valve procedure after an implant duration of six (6) years, five (5) months due to mitral stenosis and regurgitation.
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
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.
Event or Problem Description
It was reported that a patient with a 29mm 6900ptfx pericardial mitral valve underwent a valve-in-valve procedure after an implant duration of six (6) years, six (6) months due to mitral stenosis and regurgitation.The tmvr procedure was performed with a 29mm 9600tfx transcatheter valve.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13385890
• Report Number: 2015691-2022-03680
• Device Sequence Number: 4678178
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)190316
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P860057/S02
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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
• Device Expiration Date: 03/16/2019
• Device Model Number: 6900PTFX29
• Device Catalogue Number: 6900PTFX29
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/11/2022
• Date Device Manufactured: 03/17/2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male