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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure for stenosis/high gradient with a 26mm sapien 3 ultra valve in the aortic position, the valve caught the inside wall of the 14f esheath plus and caused the commander delivery system to buckle.The system would not advance past the top of the femoral head.The patient was very large.The entire system was removed from the body as a whole unit (sheath, delivery, valve) without any issue.A second 14fr sheath, 26mm delivery and 26mm sapien3 3 ultra were prepped and used.There was no harm to the patient and the second valve was deployed without issue.Per the fcs, the initial reporter did not allege the edwards devices were deficient.There were no abnormalities noted with the first sheath prior to use.The expansion tool was used, the loader cap was able to be fully inserted into the sheath/sheath housing and the valve was inserted at a steep angle.The commander caught in about the first third of the expandable section of the sheath.Per the fcs the problem was the patient was large and sheath was at sharp angle.The doctor didn't correct the angle of sheath on the first attempt.Per photo provided, the sheath had a liner strand.Per engineering review of photo provided, the valve had two bent struts and the valve frame was canted/damaged.

Manufacturer Narrative

This is one of two reports being submitted for this case.Please reference manufacturer report no.(b)(4).The investigation is ongoing.H3 other text : the valve was not returned for evaluation.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.The complaint for ''general risks - failure - frame damage'' was confirmed based on provided imagery.A review of the dhr, lot history, and complaint history 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 device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, ''during a tavr procedure for stenosis/high gradient with a 26mm sapien 3 ultra valve in the aortic position, the valve caught the inside wall of the 14f esheath plus and caused the commander delivery system to buckle.The valve was inserted at a steep angle.'' per imagery review, the flex tip was outside of the sheath.It is possible that the valve struts caught on to the sheath during withdrawal.If excessive manipulation and/or high push force was used, it can lead to distorted/canted frame and bent struts as observed.Additionally, calcification, tortuosity, and steep insertion angle can create a challenging pathway during delivery system withdrawal, which may further contribute to additional interaction between the valve and the sheath and result in the observed frame damage.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive device manipulation, high push force, insertion angle) may have contributed to the complaint 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.No corrective nor preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• 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: 17713113
• MDR Text Key: 322991555
• Report Number: 2015691-2023-15800
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260411
• 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: 10/26/2023

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: 08/15/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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