MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9600TFX29A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.H3 other text : the device remains implanted.
Event or Problem Description
As reported by a field clinical specialist (fcs), approximately 8 years and 1 month post-implant of a 29 mm sapien 3 valve in the tricuspid position via transfemoral approach, the valve failed due to stenosis and regurgitation.A 29 mm ultra resilia inside a 29 mm s3 that was implanted in 2015 in the tricuspid valve.After review of the medical records provided, stenosis was not found; however, severe central tricuspid regurgitation was revealed.The patient required a valve in valve.It was noted that the patient's elevated transvalvular mean gradient (tvmg) of 5-6mmhg was increased due to the increase in the transvalvular flow.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint was confirmed based on medical record.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of the ifu revealed no deficiencies.During the manufacturing process, all sapien 3 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.It should be noted that the sapien 3 thv was implanted in the tricuspid position in a pre-existing bioprosthetic valve for this case.Therefore, it is an off-label operation.As reported, ''approximately 8 years and 1-month post-implant of a 29 mm sapien 3 valve in the tricuspid position via transfemoral approach, the valve failed due to stenosis and regurgitation.A 29 mm ultra resilia inside a 29 mm s3 that was implanted in 2015 in the tricuspid valve.After review of the medical records provided, stenosis was not found; however, severe central tricuspid regurgitation was revealed.''.Per the instructions for use (ifu), valve regurgitation is a known potential adverse event associated with bioprosthetic heart valves and the thv procedure.Regurgitation which develops progressively over time can be due to several issues including patient-related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Additionally, per the ifu, ''safety, effectiveness, and durability have not been established for valve-in-valve procedures,''.Review of medical record revealed that the patient had history of acute kidney injury (aki) and dialysis.Aki can lead to chronic kidney disease and chronic kidney disease is a known risk factor for leaflet calcification.Leaflet calcification can impact proper coaptation of valve leaflets, leading to central regurgitation.Additionally, in this case, the transcatheter heart valve (thv) was implanted in a bio-prosthetic valve in the tricuspid position, which is an off-label operation and may have contributed to the reported event.As such, available information suggests that patient factors (acute kidney injury) and/or procedural factors (off-label operation) may have contributed to the reported event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 18301188
• Report Number: 2015691-2023-18264
• Device Sequence Number: 6936294
• Product Code: NPT
• UDI-Device Identifier: 00690103193176
• UDI-Public: (01)00690103193176(17)170630
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 9600TFX29A
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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 Age: 52 YR
• Patient Sex: Male