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

Model Number 9750TFX26

Device Problem Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2024

Event Type  Injury  

Event Description

As reported by an edwards australia affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, as the operator aligned the valve in the commander delivery system balloon, the valve overshot the distal marker, and was pushed up to the nosecone.This was due to additional turns on the wheel that the operator accidentally made during final adjustment in the descending aorta.It was decided to cross the valve with a misaligned device.However, attempts to cross the valve annulus were unsuccessful, and it was noticed that the distal part of the valve frame was flared a bit.It was decided to deploy the valve in the descending aorta.The valve was deployed without any complications.A second valve was successfully implanted in the aortic annulus.The patient was transferred to the icu in stable condition for monitoring overnight and was discharged 72 hours later.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, the reported event for valve frame damage was unable to be confirmed as no device or image was returned.As such, available information suggests that patient factors (calcification) and/or procedural factors (excessive device manipulation, improper valve alignment) may have contributed to the complaint event.There may be cases where the valve cannot be deployed at the intended location.This may require deploying the valve at a non-target location.Although well tolerated, the long-term effects are not completely understood.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: SAPIEN 3 ULTRA 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: 18826995
• MDR Text Key: 336786512
• Report Number: 2015691-2024-01558
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Model Number: 9750TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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