MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9300TFX29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist, approximately 6 years post implantation of a 29mm sapien xt valve in the aortic position the patient experienced regurgitation and underwent a valve-in-valve procedure.No patient injury was reported.
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted when additional information is provided.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned.An image review unable to be performed as images were not provided.As no device was returned, engineering was unable to perform visual inspection, functional testing, or dimensional testing.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The complaint was unable to confirmed since no relevant imagery or medical report was provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.During the manufacturing process, all sapien xt valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, "approximately 6 years post implantation of a 29mm sapien xt valve in the aortic position the patient experienced regurgitation and underwent a valve-in-valve procedure." due to insufficient information, the nature of presented regurgitation (central regurgitation and/or paravalvular leak) was unable to be confirmed.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the tavr procedure.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Due to limited information, a definitive root cause was unable to be determined at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no labeling or ifu inadequacies were identified, no corrective/preventative action nor product risk assessment is required.

• Brand Name: EDWARDS SAPIEN XT
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14189630
• Report Number: 2015691-2022-05361
• Device Sequence Number: 14573223
• Product Code: NPT
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)161211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130009
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2016
• Device Model Number: 9300TFX29A
• Device Catalogue Number: 9300TFX29A
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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
• Patient Sex: Male