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

Model Number 9755RSL26A

Device Problem Material Deformation (2976)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

As reported by the edwards field clinical specialist, during a transcatheter aortic valve replacement case by transfemoral approach, the implanter had difficulty advancing a 26mm sapien 3 ultra resilia valve and delivery system through the 14fr sheath.Under fluoroscopy, it was seen that while pushing, a valve strut was stuck at the sheath transition portion and was bent.The team decided to remove the sheath and delivery system.When the sheath was pulled out, there was bleeding noted from a tear in the seam.The implanter expected this, and had good control of the groin.A 16fr sheath was used with a new 26mm sapien 3 ultra resilia valve, and the valve was deployed without any issues.The implanter attributed the issue to the patient's anatomy (iliac tortuosity and sheath angle).There was no patient injury.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

The event reported is an 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 as it was discarded.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.The complaint for valve frame damage was unable to be confirmed based on no imagery nor device was provided for evaluation.Available information suggests patient factors (tortuosity) and/or procedural factors (high push force, steep insertion angle) likely contributed to the event as reported "the implanter had difficulty advancing a 26mm s3ur valve/delivery system through the 14fr sheath.Under fluoroscopy, it was seen that while pushing, a valve strut was stuck at the sheath transition portion and was bent" and "the implanter attributed the issue to the patient's anatomy (iliac tortuosity and sheath angle)".Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Additionally, excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.A steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.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: EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19135123
• MDR Text Key: 341467668
• Report Number: 2015691-2024-02959
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260531(11)230601
• 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: 05/16/2024

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: 9755RSL26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• 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 Sex: Male