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

Model Number 9600TFX26A

Device Problems Calcified (1077); Degraded (1153)

Patient Problem Dyspnea (1816)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device remains implanted.

Event Description

It was reported by an edwards lifesciences field clinical specialist that a patient was being worked up for a redo transcatheter aortic valve replacement (tavr) approximately 3 years and 10 months post implant of a 26mm sapien 3 valve due to calcified stenotic leaflets.As the patient is symptomatic, a valve in valve procedure is planned.

Event Description

A valve in valve procedure was done approximately 3 years 11 months post implant.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: additional information added to b5, additional information added to b7, additional codes added to h6 type of investigation, codes corrected on h6 investigation findings, codes corrected on h6 investigation conclusions.The sapien 3 (s3) valve 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.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.Imagery of the procedure was provided from the site.The following observations and impression were made by an edwards physician proctor for this procedure imaging review: calcium is noted at the right and non-coronary cusps with at least mild aortic insufficiency.An aortic mean gradient of 45mmhg was noted.The instructions for use/training manuals were reviewed for guidance/instruction involving the s3 usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 event of structural valve degeneration (svd) calcification of the valve was confirmed based on provided imagery.An existing technical summary written by edward lifesciences documents the root cause analysis on valve calcification over the time in a patient.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Edwards' thv valves undergo tissue processing, which is used to reduce calcification variability and lower calcification levels.Clinical results of thv implantation show similar mortality and significantly lower svd rate compared with surgical aortic valve replacement after 6 years of functioning.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent calcification from occurring in bioprosthetic valves.Furthermore, evaluation of reported complaints for calcification did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.In this case, patient had history of endocarditis and kidney failure.The patient had endocarditis at 11months post implant, however, it is very likely that the valve would have continued to also degenerate over time slowly.Therefore, the need for intervention may not have been due solely based on the event of endocarditis that occurred years prior to the valve in valve but was also due to patient factors (kidney disease).Kidney disease is the well-known risk factor for tissue calcification.As such, available information suggests patient factors (kidney disease) may have contributed to the complaint 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: 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: 16336762
• MDR Text Key: 309170857
• Report Number: 2015691-2023-10701
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)201003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: 9600TFX26A
• Device Catalogue Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male