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

Model Number 9750TFX

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2022

Event Type  Injury  

Event Description

As reported by field clinical specialist through the edwards hotline, approximately 2 years and 7 months post transfemoral tavr procedure, the patient underwent a valve-in-valve with a sapien 3 ultra resilia in a sapien 3 ultra valve due to calcification.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

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 imaging evaluation was unable to be performed as no imagery was 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 confirm as medical record and/or relevant imagery was not provided for evaluation.Since the valve information (i.E., serial number) was not provided for evaluation, a device history record review was unable to be performed to determine the presence of manufacturing non-conformance that potential could have contributed to the complaint event.An existing technical summary written by edwards lifesciences documents the root cause analysis on valve calcification over the time in patient.Per the technical summary, 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.Edward's transcatheter heart valve (thv) valves undergo thermafix tissue processing, which is a heat treatment process used to reduce calcification variability and lower calcification levels in comparison to xenologix process.Clinical results of thv implantation show similar mortality and significantly lower structural valve deterioration (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 similar complaints did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per the technical summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.Due to limited information available, a definitive root cause is unable to be determined.However, it was likely due to patient condition, so the technical summary is applicable to this 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.Since no edwards defect was identified, no corrective or preventative action is required.

• Brand Name: EDWARDS 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: 16110065
• MDR Text Key: 306780979
• Report Number: 2015691-2023-10005
• Device Sequence Number: 1
• Product Code: NPT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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 Model Number: 9750TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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