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 Perforation of Vessels (2135)

Event Date 10/05/2023

Event Type  Injury  

Event Description

During a tavr procedure using a 29mm sapien 3 resilia valve via transfemoral approach, the delivery system (ds) was unable to advance with valve through the iliac.The implanter was able to remove first valve without complication and tried to make adjustments to improve the chances to advance the second valve through the iliac but was not able to advance.During the attempt to remove the second valve and delivery system from patient, the valve strut poked out of the sheath and tore the right external iliac and got stuck in the common femoral and it could not be removed from the patient.As a result, a vascular surgeon was called and had to surgically remove the valve from the patient and perform a fem/fem bypass.The surgery was a success and patient was removed from room and transported to icu.

Manufacturer Narrative

The investigation is ongoing.Voluntary medsun number: (b)(4).

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-17497 and 2015691-2023-17187.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 29mm sapien 3 reslia valve was returned for examination.A visual examination found two bent struts on the inflow side, the two struts were exposed through the skirt, the frame was distorted/canted, and the leaflets were dehydrated and wrinkled due to storage conditions (prolonged crimping) during the return handling process.Functional and dimensional testing could not be performed due to the nature of the complaint.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 complaint for frame damage was confirmed based on the evaluation of the returned device.Available information suggests procedural factors (excessive manipulation/high push force) likely contributed to the event as two struts on the inflow side were observed to be bent.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in 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.A previous product risk assessment was initiated to capture this event.

• 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: 18046686
• MDR Text Key: 327049934
• Report Number: 2015691-2023-17182
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260521(11)2305222110698730
• 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: 12/22/2023

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: 9755RSL29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 74 KG