MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US SAPIEN 3 ULTRA VALVE 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691 2024 01201.

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra valve in aortic position.During the procedure, when the physician tried to place the first sheath, the tip buckled at the skin level.When the physician pulled it out, it was noticed to be bent at the tip of the sheath.It was decided to open a new 14 fr esheath.The second sheath was placed and as the physician advanced the 26mm valve through the sheath he was unable to advance it anymore.He tried to pull the sheath and valve out but was unable to do so.The team noticed that it appeared the valve was through the sheath in the external iliac.The surgeon performed a surgical cutdown to remove the valve.The case was aborted to let the patient stabilize and recover and the valve was not implanted.As per follow-up with the fcs, the devices were prepped correctly and the expansion tool was used.The insertion angle was not steep and the dilator was fully inserted.The vessel was pre-dilated with a 16fr dilator.The first esheath damage was clarified as just the tip was bent up.The 2nd esheath damage was clarified as "torn all the way up to the white portion." there was no damage to the valve.The valve did not make it out of the tip of the esheath.Regarding the statement "it appeared the valve was through the sheath in the external iliac" it was clarified that there was damage to the esheath and there was vascular damage due to the cut-down.The patient was discharged home and will be rescheduled at a later date.The fcs will be returning the second sheath, commander system and the valve.Per pre-decontamination findings and additional discussion with engineering, it was noted that there was a bent strut on inflow end of valve.Per additional follow-up with the fcs, when the delivery system and sheath were stuck in the patient, they had to cut it but they also used various clamps to try and occlude the lumen as much as possible until they were able to get control.They did not notice the bent struts as the valve was still in the sheath, but the fcs wondered if some of that may have been from them trying to push/pull the sheath out.

• Brand Name: US SAPIEN 3 ULTRA VALVE 26MM
• 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: 19199474
• MDR Text Key: 341270997
• Report Number: 2015691-2024-03200
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260920
• 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
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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