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

Model Number 9750TFX26A

Device Problem Device Damaged by Another Device (2915)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing device not returned.

Event Description

As reported, upon insertion of the delivery system into the 14fr e-sheath, the sheath kinked at the skin and the valve strut came through the side wall of the sheath outside of the body, one of the valve struts was partially bent due to the valve hitting the kink in the sheath.They retrieved the valve, sheath and delivery system from the patient and a 16fr e-sheath was requested and inserted.They prepared a new valve and delivery system and the procedure went on as normal without any complications or harm to the patient.

Manufacturer Narrative

H2, h6 updated.Component code 527 is no longer applicable the valve was not returned; therefore, a visual inspection, functional testing, or dimensional testing was not performed.Imagery was provided by the site and revealed the following: patients vasculature had presence of tortuosity.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.The complaint for failure frame damage was unable to be confirmed, therefore a lot history review and complaint history review is not required.The following instructions for use (ifu) and manual were reviewed: commander delivery system with s3/s3u/s3ur ifu, us, s3u, commander, esheath+ device preparation, s3u, commander, esheath+ procedural manual.No ifu or training deficiencies were identified.No device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, therefore a manufacturing mitigation review is not required.A risk assessment was performed on the reported event and revealed no evidence of product non conformances or labeling/ifu inadequacies.The complaint for failure frame damage was unable to be confirmed due to unavailability of returned device/relevant imagery/medical records.A review of the dhr and lot history did not provide any indication that a manufacturing nonconformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.As reported, upon insertion of the delivery system into 14fr esheath, the sheath kinked at the skin and the valve strut came through the side wall of the sheath outside of the body.One of the valve struts was partially bent due to the valve hitting the kink in the sheath.The strut punctured through the sidewall of the sheath.Per training manual, push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification, and do not overmanipulate the sheath at any time.In this case, it is likely that the kinked sheath created a restricted pathway during delivery system advancement, and further excessive device manipulation leads to valve struts interacting with the sheath shaft, resulting in valve bent strut.As such, available information suggests that procedural factors (excessive device manipulation, sheath kinked) may have contributed to the complaint event.However, a definitive root cause was unable to be determined.Since no manufacturing nonconformances or labeling and ifu and training deficiencies were identified, no product nonconformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective and preventative actions (capa) nor product risk assessment (pra) escalation 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: 16156127
• MDR Text Key: 307298955
• Report Number: 2015691-2023-10145
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)250719
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

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: 12/21/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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