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

Model Number 9600TFX26A

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by a field clinical specialist, the patient had a pre-existing non-ew mitral angioplasty ring implanted in the mitral position in 2010.The patient presented with the increased shortness of breath and dyspnea on exertion and with mitral regurgitation, therefore a 26 mm sapien 3 ultra valve was implanted in the mitral position via transfemoral approach.Approximately two years post implant the patient was observed to have severe stenosis and a 26 mm sapien 3 ultra valve was prepped and deployed valve in valve.The patient's stenosis resolved.The patient was in stable condition post procedure.The cause of the reported stenosis is unknown.

Manufacturer Narrative

The product was not returned for evaluation.No applicable imagery was provided for review.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for the proper use of the device and no deficiencies were identified.During the manufacturing process, the sapien 3 ultra valve is visually inspected and tested several times.During manufacturing the valve frame component was 100% inspected.During the final inspection, the valve underwent 100% inspection by both manufacturing and quality.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 the failure mode is not required at this time.The complaint for post implantation stenosis was unable to be confirmed.A review of the dhr and lot history revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of manufacturing mitigations supports that the sapien 3 ultra valve had proper inspections in place to detect issues related to the complaint events.A review of ifu training revealed no deficiencies.During the manufacturing process, all sapien 3 ultra 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.Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including calcification, support structure deformation (out-of-round configuration), trauma (cardio-pulmonary resuscitation, blunt chest trauma), and native leaflet prolapse impeding prosthetic leaflet motion.Due to insufficient of information, a definitive root cause was unable to be determined at this time.Due to the unavailability of the device, it cannot be determined if a manufacturing nonconformance contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: MITRAL VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11289283
• MDR Text Key: 230688351
• Report Number: 2015691-2021-01161
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR