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

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences field clinical specialist, struts of the 29mm sapien 3 ultra resilia valve were noted exiting the partially expandable portion of the first 16fr esheath+.Access was obtained via the right femoral artery.No abnormalities were noted on the 16fr esheath+ during device preparation.The vessel was pre-dilated with the 18fr dilator.The 16fr esheath+ was inserted at an increased angle due to the patient's body habitus.The physician met resistance when inserting the 29mm sapien 3 ultra resilia valve and 29mm commander delivery system through the partially expandable portion of the sheath.The team decided to remove the entire delivery system and sheath as a unit.Upon removal, valve struts were noted exiting the partially expandable portion of the sheath.The valve struts appeared bent from the force during the attempt at insertion.A second non-ew sheath was prepared and inserted.Resistance was met again when advancing the second 29mm commander delivery system and 29mm sapien 3 ultra resilia valve, so the entire delivery system and sheath were removed.Ultimately a third non-ew sheath was inserted, and a 29mm sapien 3 valve was able to be advanced without issue.The valve was successfully implanted in the aortic position.No vascular complications or other issues arose.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the engineering evaluation.The following sections of this report have been updated: corrected h.6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions.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 discarded and was not returned to edwards lifesciences.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was provided by the site and revealed the following: patient's right access vessel had presence of tortuosity.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 valve frame damage was unable to be confirmed based on no device imagery provided for evaluation.Available information suggests patient factors (tortuosity) and/or procedural factors (high push force, insertion 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.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.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.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 (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: 19093956
• MDR Text Key: 340569212
• Report Number: 2015691-2024-02800
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260618(11)230619
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 9755RSL29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 147 KG