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

Model Number 9750TFX26A

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Device not returned h3 other text : device not returned.

Event Description

As reported, the valve alignment in abdominal aorta was very tortuous, and the valve dived over the pusher during alignment which caused one of the struts of the outflow of the valve to bend at a 45 degree angle.The operators decided not to withdraw the valve, and deployed in the aorta without issue or patient injury.The strut bend was gone and the valve looked great with good expansion.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected d.1 brand name.Additional information d.6 implant date.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.1 type of reportable event, h.6 component code, device code and 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 no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed due to unavailability of returned device and/or relevant imagery.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, ''the valve alignment in abdominal aorta was very tortuous, and the valve dived over the pusher during alignment which caused one of the struts of the outflow of the valve to bend at a 45-degree angle''.Per training manual, ''if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the vasculature and relieving compression (or tension) in the system will be necessary.Additionally, per the procedural manual, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification'' and ''if push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system''.Performing valve alignment in tortuous vasculature can result in a higher force required to align the valve.In this case, if excessive force is applied to manipulate the device during valve alignment, it can lead to the valve struts catching the delivery system flex tip and resulted in the reported frame damage at the outflow side.As such, available information suggests that procedural factors (valve alignment in non-straight section, excessive device manipulation) 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.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: EDWARDS 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: 17799652
• MDR Text Key: 324050956
• Report Number: 2015691-2023-16109
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/03/2023; 11/13/2023
• Supplement Dates FDA Received: 11/10/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male